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This chronic, prospective, non-randomized feasibility study is designed to evaluate the Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling pressures from the Chronicle device to provide timely medication adjustments (diuretics) to subjects.
Subjects will be asked to transmit to the CareLink Network daily. Data specific to this study (subject's daily estimated Pulmonary Arterial Diastolic (ePAD) pressure values) will be extracted from the CareLink database and transferred to the IPC clinician website.
As each subject is enrolled, clinicians at each participating site will determine the appropriate target pressure range for each subject based on a review of the subject's pressure data. Each day after enrollment, the subject's current pressure data will be compared to a target pressure range that the clinician sets for that subject.
The patient instruction set (PtIS) is limited to a daily diuretic prescription and associated supplements, per physician discretion. The PtIS should not include adjustments of non-heart failure medications and should not include heart failure medications that are not indicated for day-to-day adjustments (e.g. ACE-Inhibitors, Angiotensin Receptor Blockers (ARBs), and Beta-Blockers). The PtIS will be sent from the IPC clinician website to the subject through a Patient Home Monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily diuretic adjustment | Other | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diuretics | Drug | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Technical Feasibility of the Network Based IPC System | The proportion of study days a PtIS is based on the subjects' daily pressure state | Baseline through Completion/Exit (an average of 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Rate of IPC Setup System Changes | The frequency of changes in the IPC setup during the study (an average of 3-months). | Baseline through Completion/Exit (an average of 3-months) |
| Quantify Subject Compliance to Daily PtIS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Adamson, MD | Oklahoma Cardiovascular Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States | ||
| Oklahoma Cardiovascular Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Diuretic Adjustment | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Diuretic Adjustment | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
| 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 | Characterize the Technical Feasibility of the Network Based IPC System | The proportion of study days a PtIS is based on the subjects' daily pressure state | The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor. | Posted | Mean | 95% Confidence Interval | percentage of days | Baseline through Completion/Exit (an average of 3 months) | Days | Days |
|
All serious adverse events, cardiovascular related adverse events, and events related to the IPC system were captured from study enrollment through the study exit (approximately 60 days post-enrollment)
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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 | Daily Diuretic Adjustment | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
The IPC study was a research feasibility study and was not powered to test any specific stastistical hypotheses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Fonseca, VP Clinical | Medtronic | 763-526-8151 | todd.fonseca@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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The proporition of IPC days study subjects indicated they complied with their PtIS.
| Baseline through Completion/Exit (on average 3-months) |
| Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months). | Baseline through Completion/Exit (an average of 3-months) |
| Summarize Adverse Events | All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized. | Baseline through Completion/Exit (an average of 3-months) |
| Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months). | Baseline through Completion/Exit (an average of 3-months) |
| Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in blood urea nitrogen from baseline to study exit (an average of 3-months). | Baseline through Completion/Exit (an average of 3-months) |
| Oklahoma City |
| Oklahoma |
| 73120 |
| United States |
| Sentara Cardiovascular | Norfolk | Virginia | 23507 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association Classification | The New York Heart Association (NYHA) Functional Classification classifies the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity. Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, 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 Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Days |
|
|
|
| Secondary | Characterize the Rate of IPC Setup System Changes | The frequency of changes in the IPC setup during the study (an average of 3-months). | The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained | Posted | Number | 95% Confidence Interval | changes per day | Baseline through Completion/Exit (an average of 3-months) |
|
|
|
| Secondary | Quantify Subject Compliance to Daily PtIS | The proporition of IPC days study subjects indicated they complied with their PtIS. | The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS | Posted | Number | 95% Confidence Interval | proportion of compliant days | Baseline through Completion/Exit (on average 3-months) |
|
|
|
| Secondary | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months). | Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits | Posted | Mean | Standard Deviation | pg/dL | Baseline through Completion/Exit (an average of 3-months) |
|
|
|
| Secondary | Summarize Adverse Events | All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized. | All 21 subjects participating in the IPC study | Posted | Count of Participants | Participants | Baseline through Completion/Exit (an average of 3-months) |
|
|
|
| Secondary | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months). | Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Baseline through Completion/Exit (an average of 3-months) |
|
|
|
| Secondary | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Changes in blood urea nitrogen from baseline to study exit (an average of 3-months). | Subjects with blood urea nitrogen values at both the baseline and study exit visits | Posted | Mean | Standard Deviation | mg/dL | Baseline through Completion/Exit (an average of 3-months) |
|
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| 4 |
| 21 |
| Myocardial Infarction | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Mental status change | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
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| No |
|
| PtIS Related Adverse Events |
|
| Heart Failure Related Adverse Event |
|
| Cardiovascular Related Adverse Event |
|