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Limited beta-blocker naive participants among newly diagnosed heart failure participants, which led barrier to the recruitments.
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| Name | Class |
|---|---|
| Merck Serono Co., Ltd., China | INDUSTRY |
Not provided
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This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisoprolol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol | Drug | Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Resting Heart Rate at Week 6 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Baseline, Week 6 |
| Change From Baseline in Resting Heart Rate at Week 14 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Baseline, Week 14 |
| Change From Baseline in Resting Heart Rate at Week 26 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Resting Heart Rate at Week 3, 10 and 18 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Baseline, Week 3, 10 and 18 |
| Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono Co., Ltd., China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | 100037 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bisoprolol | Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bisoprolol | Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26. |
| 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 | Change From Baseline in Resting Heart Rate at Week 6 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 6 |
|
|
Baseline up to Week 26
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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 | Bisoprolol | Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
The study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Jan 9, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF. |
| Baseline, Week 14 and 26 |
| Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26 | Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram. | Baseline, Week 14 and 26 |
| Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26 | Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram. | Baseline, Week 14 and 26 |
| Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26 | Interventricular septal thickness was measured by Ultrasound cardiogram. | Baseline, Week 14 and 26 |
| Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26 | Early to late ratio was measured by ultrasound cardiogram. | Baseline, Week 14 and Week 26 |
| Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure | Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator. | Screening (Week -2) up to Week 26 |
| Number of Participants With New York Heart Association (NYHA) Class | The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased. | Baseline, Week 26 |
| Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm | Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate. | Baseline up to Week 26 |
| Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment | MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life. | Baseline, end of treatment (Week 26) |
| Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment | Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. | Baseline, end of treatment (Week 26) |
| 6-Minute Walk Test | 6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes. | Baseline and End of treatment (Week 26) |
| Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP) | Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value). | Baseline up to End of treatment (Week 26) |
| Mean 24 Hour, Day Time and Night Time Heart Rate | Holter monitor was used to measure heart rate (24 hour, day time, night time). | Baseline, week 6, 14 and end of treatment (Week 26) |
| Number of Participants With Arrhythmia | Holter monitor was used to diagnose arrhythmia. | Baseline up to end of treatment (Week 26) |
| Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm | Holter monitor was used to measure heart rate. | Baseline, week 6, 14 and end of treatment (Week 26) |
| Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR) | MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (<) 80% or greater than (>)100% is defined as insufficient compliance. | Up to Week 26 |
| Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure | Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported. | Up to Week 26 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| Secondary | Change From Baseline in Resting Heart Rate at Week 3, 10 and 18 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 3, 10 and 18 |
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26 | LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 and 26 |
|
|
| Secondary | Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26 | Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 and 26 |
|
|
| Secondary | Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26 | Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 and 26 |
|
|
| Secondary | Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26 | Interventricular septal thickness was measured by Ultrasound cardiogram. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 and 26 |
|
|
| Secondary | Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26 | Early to late ratio was measured by ultrasound cardiogram. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 and Week 26 |
|
|
| Secondary | Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure | Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator. | The safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Screening (Week -2) up to Week 26 |
|
|
|
| Secondary | Number of Participants With New York Heart Association (NYHA) Class | The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased. | The safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline, Week 26 |
|
|
|
| Secondary | Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm | Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate. | The safety population included all subjects who received at least one dose of study treatment. | Posted | Number | percentage of participants | Baseline up to Week 26 |
|
|
|
| Secondary | Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment | MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, end of treatment (Week 26) |
|
|
| Secondary | Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment | Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, end of treatment (Week 26) |
|
|
| Secondary | 6-Minute Walk Test | 6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline and End of treatment (Week 26) |
|
|
| Secondary | Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP) | Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value). | The safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to End of treatment (Week 26) |
|
|
|
| Secondary | Mean 24 Hour, Day Time and Night Time Heart Rate | Holter monitor was used to measure heart rate (24 hour, day time, night time). | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, week 6, 14 and end of treatment (Week 26) |
|
|
| Secondary | Number of Participants With Arrhythmia | Holter monitor was used to diagnose arrhythmia. | The safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline up to end of treatment (Week 26) |
|
|
|
| Secondary | Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm | Holter monitor was used to measure heart rate. | The safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline, week 6, 14 and end of treatment (Week 26) |
|
|
|
| Secondary | Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR) | MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (<) 80% or greater than (>)100% is defined as insufficient compliance. | The safety population included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 26 |
|
|
|
| Secondary | Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure | Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported. | The safety population included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 26 |
|
|
|
| Primary | Change From Baseline in Resting Heart Rate at Week 14 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 14 |
|
|
| Primary | Change From Baseline in Resting Heart Rate at Week 26 | Heartbeats in each minute were calculated and averaged to obtain the resting heart rate. | Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment. | Posted | Baseline, Week 26 |
|
|
| 1 |
| 20 |
| 4 |
| 20 |
| 10 |
| 20 |
| Sudden death | General disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Sinoatrial block | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection 3 (15.0) | Infections and infestations | MedDRA version 21.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 21.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 21.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|
| Week 26: NYHA class II |
|
| Week 26: NYHA class III |
|
| Week 26: NYHA class IV |
|
| Week 26: Not evaluated |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|