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The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.
Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFrEF | Experimental | Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
|
| HFpEF | Experimental | Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVIVO Mobile Patient Management (MPM) System | Device | Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Steps Count | Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. | At Day 9 and Day 77 |
| Daily Physical Activity Level | Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity. | At Day 9 and Day 77 |
| Total Daily Energy Expenditure | Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. | At Day 9 and Day 77 |
| Duration of Daily Physical Activity | Duration of daily physical activity was measured with DynaPort Move Monitor device. | At Day 9 and Day 77 |
| Time Duration Per Activity Status | Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more. | At Day 9 and Day 77 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute Walking Distance (6MWD) | 6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. | At Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by the investigator. |
Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Universitätsklinikum Köln |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Overall, 29 participants were screened, of which 2 participants were screening failures and 27 participants received at least one device.
The study was conducted at multiple centers in 3 countries between 06 APR 2018 (first participant first visit) and 12 MAR 2021 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | HFrEF | Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| FG001 | HFpEF | Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Full analysis set (FAS) : all participants that were enrolled into the study and that wore at least one device
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| ID | Title | Description |
|---|---|---|
| BG000 | HFrEF | Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Steps Count | Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. | Device set (DES): All participants with DynaPort parameters for least one wearing period | Posted | Mean | Standard Deviation | Steps | At Day 9 and Day 77 |
|
From signing the informed consent form (ICF) until follow-up visit (up to 7 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HFrEF | Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. No evaluation was possible within this report. Further, activity data of the previous AVIVO patch as well as of the VitalPatch biosensor were not found to be scientifically evaluable. Activity data therefore were decided to be evaluated based on the DynaPort output only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2020 | Mar 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2021 | Mar 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| VitalPatch biosensor | Device | Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study |
|
| DynaPort Move Monitor | Device | Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study |
|
| Amount of Daily Physical Activity Measured With VitalPatch Biosensor | Amount of daily physical activity was collected and measured with VitalPatch biosensor. | Up to Day 84 |
| Duration of Daily Physical Activity Measured With VitalPatch Biosensor | Duration of daily physical activity was collected and measured with VitalPatch biosensor. | Up to Day 84 |
| Intensity of Daily Physical Activity Measured With VitalPatch Biosensor | Intensity of daily physical activity was collected and measured with VitalPatch biosensor. | Up to Day 84 |
| Sleep Movements |
Sleep movements was measured with DynaPort Move Monitor device. |
| Up to Day 84 |
| Sleep Patterns | Sleep patterns was measured with DynaPort Move Monitor device. | Up to Day 84 |
| Sit-to-stand Behaviour | Sit-to-stand behaviour was measured with DynaPort Move Monitor device. | Up to Day 84 |
| Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients' HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states. | At Day 9 and Day 84 |
| Quality of Life as Measured With the PRO - Activity Scores | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states. | At Day 9 and Day 77 |
| Quality of Life as Measured With the PRO - Change in Activities and Symptoms | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question "How have your physical activities changed since you were discharged from the hospital": 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions "How has your feeling of tiredness changed since you were discharged from the hospital", "How has your shortness of breath changed since you were discharged from the hospital" and "How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital": 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. | At Day 9 and Day 77 |
| Copeptin | Blood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | At Day 9 and Day 84 |
| Galectin-3 | Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | At Day 9 and Day 84 |
| Growth Differentiation Factor 15 (GDF 15) | Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | At Day 9 and Day 84 |
| Human Interleukin-1 Receptor 4 / ST2 (sST2) | Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0) | At Day 9 and Day 84 |
| Human Insulin-like Growth Factor Binding (IGFBP7) | Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | At Day 9 and Day 84 |
| N-terminal Propeptide of BNP (NT-proBNP) | Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | At Day 9 and Day 84 |
| High Sensitive Troponin T (hsTRT) | Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0) | At Day 9 and Day 84 |
| Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected. | At Day 9, Day 77 and Day 84 |
| Heart Rate | Heart rate data were collected by electrocardiogram (ECG). | At Day 9, Day 77 and Day 84 |
| Interventricular Septal Wall Thickness | Interventricular septal wall thickness was measured by echocardiography. | At Day 84 |
| Diameter of the Left Ventricle in Diastole | Diameter of the left ventricle in diastole was measured by echocardiography. | At Day 84 |
| Diameter of the Left Ventricle in Systole | Diameter of the left ventricle in systole was measured by echocardiography. | At Day 84 |
| Left Ventricular End-diastolic Volume | Left ventricular end-diastolic volume was measured by echocardiography. | At Day 84 |
| Left Ventricular End-systolic Volume | Left ventricular end-systolic volume was measured by echocardiography. | At Day 84 |
| Left Ventricular Ejection Fraction | Left ventricular ejection fraction was measured by echocardiography. | At Day 84 |
| Left Atrial End-systolic Volume | Left atrial end-systolic volume was measured by echocardiography. | At Day 84 |
| Left Atrial End Systolic Volume Index | Left atrial end systolic volume index was measured by echocardiography. | At Day 84 |
| Mitral Peak Velocity of Early Filling (E) | Mitral peak velocity of early filling (E) was measured by echocardiography. | At Day 84 |
| Mitral Peak Velocity of Late Filling (A) | Mitral peak velocity of late filling (A) was measured by echocardiography. | At Day 84 |
| Mitral Lateral Annulus Early Diastolic Peak Velocity | Mitral lateral annulus early diastolic peak velocity was measured by echocardiography. | At Day 84 |
| Mitral Septal Annulus Early Diastolic Peak Velocity | Mitral septal annulus early diastolic peak velocity was measured by echocardiography. | At Day 84 |
| Tricuspid Annular Plane Systolic Excursion | Tricuspid annular plane systolic excursion was measured by echocardiography. | At Day 84 |
| Pressure Gradient of Tricuspid Valve | Pressure gradient of tricuspid valve was measured by echocardiography. | At Day 84 |
| Right Atrial Mean Pressure | Right atrial mean pressure was measured by echocardiography. | At Day 84 |
| Heart Rate Variability (HRV) Derived From ECG | Heart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensor | Up to Day 84 |
| Number of Participants Per NYHA Classification by Visit | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II = Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III = Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | At Day 9 and Day 84 |
| From signing the ICF until follow-up visit (up to 7 months) |
| Cologne |
| North Rhine-Westphalia |
| 50937 |
| Germany |
| Heinrich-Heine-Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Charité - Campus Virchow-Klinikum (CVK) | Berlin | 13353 | Germany |
| ASST Spedali Civili di Brescia | Brescia | Lombardy | 25123 | Italy |
| Death |
|
| BG001 |
| HFpEF |
Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 6-minute walking distance (6MWD) | 6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Full Range | Meters (m) |
|
| Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire score | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Median | Full Range | Scores on a scale |
|
| Copeptin | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Picomoles per litre (pmol/L) |
|
| Galectin-3 | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) |
|
| Growth differentiation factor 15 (GDF 15) | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Picograms per millilitre (pg/mL) |
|
| Human interleukin-1 Receptor 4 / ST2 | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Picograms per litre (pg/L) |
|
| Human Insulin-like Growth Factor Binding | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) |
|
| N-terminal propeptide of BNP (NT-proBNP) | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Nanograms per liter (ng/L) |
|
| High sensitive Troponin T | Biomarkers were determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0) | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Picograms per millilitre (pg/mL) |
|
| Blood pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | millimetre of mercury (mmHg) |
|
| Heart rate | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Beats per minute |
|
| Interventricular septal wall thickness | Interventricular septal wall thickness was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimeters (mm) |
|
| Diameter of the left ventricle in diastole | Diameter of the left ventricle in diastole was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimeters (mm) |
|
| Diameter of the left ventricle in systole | Diameter of the left ventricle in systole was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimeters (mm) |
|
| Left ventricular end-diastolic volume | Left ventricular end-diastolic volume was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Milliliter (mL) |
|
| Left ventricular end-systolic volume | Left ventricular end-systolic volume was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Milliliter (mL) |
|
| Left ventricular ejection fraction | Left ventricular ejection fraction was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Percentage of the volumn of blood |
|
| Left atrial end-systolic volume | Left atrial end-systolic volume was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Milliliter (mL) |
|
| Left atrial end systolic volume index | Left atrial end systolic volume index was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Milliliter per square meter (mL/m^2) |
|
| Mitral peak velocity of late filling (A) | Mitral peak velocity of late filling (A) was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Centimeter per second (cm/sec) |
|
| Mitral peak velocity of early filling (E) | Mitral peak velocity of early filling (E) was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Centimeter per second (cm/sec) |
|
| Mitral lateral annulus early diastolic peak velocity | Mitral lateral annulus early diastolic peak velocity was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Centimeter per second (cm/sec) |
|
| Mitral septal annulus early diastolic peak velocity | Mitral septal annulus early diastolic peak velocity was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Centimeter per second (cm/sec) |
|
| Tricuspid annular plane systolic excursion | Tricuspid annular plane systolic excursion was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimeters (mm) |
|
| Pressure gradient of tricuspid valve | Pressure gradient of tricuspid valve was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimetre of mercury (mmHg) |
|
| Right atrial mean pressure | Right atrial mean pressure was measured by echocardiography. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Mean | Standard Deviation | Millimetre of mercury (mmHg) |
|
| Number of participants per NYHA classification | New York Heart Association (NYHA) Classification: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II = Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III = Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Participants in full analysis set (FAS) with evaluable data for this evaluation | Count of Participants | Participants |
|
Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77.
|
|
| Primary | Daily Physical Activity Level | Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity. | Device set (DES): All participants with DynaPort parameters for least one wearing period | Posted | Mean | Standard Deviation | Meter*second^-2 (m*s^-2) | At Day 9 and Day 77 |
|
|
|
| Primary | Total Daily Energy Expenditure | Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity. | Device set (DES): All participants with DynaPort parameters for least one wearing period | Posted | Mean | Standard Deviation | Kilocalorie (kcal) | At Day 9 and Day 77 |
|
|
|
| Primary | Duration of Daily Physical Activity | Duration of daily physical activity was measured with DynaPort Move Monitor device. | Device set (DES): All participants with DynaPort parameters for least one wearing period | Posted | Mean | Standard Deviation | Hours | At Day 9 and Day 77 |
|
|
|
| Primary | Time Duration Per Activity Status | Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more. | Device set (DES): All participants with DynaPort parameters for least one wearing period | Posted | Mean | Standard Deviation | Hours | At Day 9 and Day 77 |
|
|
|
| Secondary | 6-minute Walking Distance (6MWD) | 6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Full Range | Meters | At Day 84 |
|
|
|
| Secondary | Sleep Movements | Sleep movements was measured with DynaPort Move Monitor device. | No participant in device set (DES) with evaluable data for this evaluation | Posted | Up to Day 84 |
|
|
| Secondary | Sleep Patterns | Sleep patterns was measured with DynaPort Move Monitor device. | No participant in device set (DES) with evaluable data for this evaluation | Posted | Up to Day 84 |
|
|
| Secondary | Sit-to-stand Behaviour | Sit-to-stand behaviour was measured with DynaPort Move Monitor device. | No participant in device set (DES) with evaluable data for this evaluation | Posted | Up to Day 84 |
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| Secondary | Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients' HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Median | Full Range | Scores on a scale | At Day 9 and Day 84 |
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| Secondary | Quality of Life as Measured With the PRO - Activity Scores | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Median | Full Range | Scores on a scale | At Day 9 and Day 77 |
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| Secondary | Quality of Life as Measured With the PRO - Change in Activities and Symptoms | REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question "How have your physical activities changed since you were discharged from the hospital": 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions "How has your feeling of tiredness changed since you were discharged from the hospital", "How has your shortness of breath changed since you were discharged from the hospital" and "How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital": 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Median | Full Range | Scores on a scale | At Day 9 and Day 77 |
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| Secondary | Copeptin | Blood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Picomoles per litre (pmol/L) | At Day 9 and Day 84 |
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| Secondary | Galectin-3 | Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | At Day 9 and Day 84 |
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| Secondary | Growth Differentiation Factor 15 (GDF 15) | Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Picograms per millilitre (pg/mL) | At Day 9 and Day 84 |
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| Secondary | Human Interleukin-1 Receptor 4 / ST2 (sST2) | Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0) | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Picograms per litre (pg/L) | At Day 9 and Day 84 |
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| Secondary | Human Insulin-like Growth Factor Binding (IGFBP7) | Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | At Day 9 and Day 84 |
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| Secondary | N-terminal Propeptide of BNP (NT-proBNP) | Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Nanograms per liter (ng/L) | At Day 9 and Day 84 |
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| Secondary | High Sensitive Troponin T (hsTRT) | Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0) | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Picograms per millilitre (pg/mL) | At Day 9 and Day 84 |
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| Secondary | Blood Pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | millimetre of mercury (mmHg) | At Day 9, Day 77 and Day 84 |
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| Secondary | Heart Rate | Heart rate data were collected by electrocardiogram (ECG). | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Mean | Standard Deviation | Beats per minute | At Day 9, Day 77 and Day 84 |
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| Secondary | Interventricular Septal Wall Thickness | Interventricular septal wall thickness was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimeters (mm) | At Day 84 |
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| Secondary | Diameter of the Left Ventricle in Diastole | Diameter of the left ventricle in diastole was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimeters (mm) | At Day 84 |
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| Secondary | Diameter of the Left Ventricle in Systole | Diameter of the left ventricle in systole was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimeters (mm) | At Day 84 |
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| Secondary | Left Ventricular End-diastolic Volume | Left ventricular end-diastolic volume was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Milliliter (mL) | At Day 84 |
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| Secondary | Left Ventricular End-systolic Volume | Left ventricular end-systolic volume was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Milliliter (mL) | At Day 84 |
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| Secondary | Left Ventricular Ejection Fraction | Left ventricular ejection fraction was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Percentage of the volume of blood | At Day 84 |
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| Secondary | Left Atrial End-systolic Volume | Left atrial end-systolic volume was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Milliliter (mL) | At Day 84 |
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| Secondary | Left Atrial End Systolic Volume Index | Left atrial end systolic volume index was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Milliliter per square meter (mL/m^2) | At Day 84 |
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| Secondary | Mitral Peak Velocity of Early Filling (E) | Mitral peak velocity of early filling (E) was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Centimeter per second (cm/sec) | At Day 84 |
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| Secondary | Mitral Peak Velocity of Late Filling (A) | Mitral peak velocity of late filling (A) was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Centimeter per second (cm/sec) | At Day 84 |
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| Secondary | Mitral Lateral Annulus Early Diastolic Peak Velocity | Mitral lateral annulus early diastolic peak velocity was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Centimeter per second (cm/sec) | At Day 84 |
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| Secondary | Mitral Septal Annulus Early Diastolic Peak Velocity | Mitral septal annulus early diastolic peak velocity was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Centimeter per second (cm/sec) | At Day 84 |
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| Secondary | Tricuspid Annular Plane Systolic Excursion | Tricuspid annular plane systolic excursion was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimeters (mm) | At Day 84 |
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| Secondary | Pressure Gradient of Tricuspid Valve | Pressure gradient of tricuspid valve was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimetre of mercury (mmHg) | At Day 84 |
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| Secondary | Right Atrial Mean Pressure | Right atrial mean pressure was measured by echocardiography. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data for this assessment | Posted | Mean | Standard Deviation | Millimetre of mercury (mmHg) | At Day 84 |
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| Secondary | Heart Rate Variability (HRV) Derived From ECG | Heart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensor | Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. | Posted | Up to Day 84 |
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| Secondary | Number of Participants Per NYHA Classification by Visit | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II = Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III = Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Participants in full analysis set (FAS, all participants that were enrolled into the study and that wore at least one device) with evaluable data on each evaluation day for this assessment | Posted | Count of Participants | Participants | At Day 9 and Day 84 |
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| Other Pre-specified | Number of Participants With Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant after providing written informed consent for participation in the study. An AE may or may not be temporally or causally associated with the use of a medicinal product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by the investigator. | Full analysis set (FAS): All participants that were enrolled into the study and that wore at least one device | Posted | Count of Participants | Participants | From signing the ICF until follow-up visit (up to 7 months) |
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| Primary | Amount of Daily Physical Activity Measured With VitalPatch Biosensor | Amount of daily physical activity was collected and measured with VitalPatch biosensor. | Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. | Posted | Up to Day 84 |
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| Primary | Duration of Daily Physical Activity Measured With VitalPatch Biosensor | Duration of daily physical activity was collected and measured with VitalPatch biosensor. | Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. | Posted | Up to Day 84 |
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| Primary | Intensity of Daily Physical Activity Measured With VitalPatch Biosensor | Intensity of daily physical activity was collected and measured with VitalPatch biosensor. | Due to non-compatibility of systems, data could not be derived from the VitalPatch biosensor at the time of report preparation. | Posted | Up to Day 84 |
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| 1 |
| 14 |
| 5 |
| 14 |
| 8 |
| 14 |
| EG001 | HFpEF | Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. | 1 | 13 | 3 | 13 | 9 | 13 |
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Pneumonia legionella | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Klebsiella sepsis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Mitral valve repair | Surgical and medical procedures | MedDRA (24.0) | Non-systematic Assessment |
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| Cardiovascular disorder | Cardiac disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Thyroid mass | Endocrine disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Tongue disorder | Gastrointestinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Face oedema | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (24.0) | Non-systematic Assessment |
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| Catheterisation cardiac | Investigations | MedDRA (24.0) | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Non-systematic Assessment |
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| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (24.0) | Non-systematic Assessment |
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Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Day 77 |
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| Day 77 |
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| Active Time - Day 77 |
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| Time in Sedentary State - Day 77 |
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| Time in Light Activity State - Day 9 |
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| Time in Light Activity State - Day 77 |
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| Time in Moderate Activity State - Day 9 |
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| Time in Moderate Activity State - Day 77 |
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| Time in Vigorous Activity State - Day 9 |
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| Time in Vigorous Activity State - Day 77 |
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| Total Symptom Score - Day 84 |
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| Clinical Summary Score - Day 9 |
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| Clinical Summary Score - Day 84 |
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| Overall Summary Score - Day 9 |
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| Overall Summary Score - Day 84 |
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| Physical Limitation Score - Day 9 |
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| Physical Limitation Score - Day 84 |
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| Overall Activity Score - Day 77 |
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| General Physical Activity Score - Day 9 |
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| General Physical Activity Score - Day 77 |
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| How Have Your Physical Activities Changed Since Discharged from Hospital - Day 77 |
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| How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 9 |
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| How Has Your Feeling of Tiredness Changed Since Discharged from Hospital - Day 77 |
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| How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 9 |
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| How Has Your Shortness of Breath Changed Since Discharged from Hospital - Day 77 |
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| How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 9 |
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| How Has Your Swelling in Your Legs, Ankles, or Feet Changed Since Discharged from Hospital - Day 77 |
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| Day 84 |
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| Day 84 |
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| Day 84 |
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| Day 84 |
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| Day 84 |
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| Day 84 |
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| Day 84 |
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| SBP - Day 77 |
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| SBP - Day 84 |
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| DBP - Day 9 |
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| DBP - Day 77 |
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| DBP - Day 84 |
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| Day 77 |
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| Day 84 |
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| NYHA CLASS II |
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| NYHA CLASS III |
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| Day 84 |
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