Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Diuretics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle ICD device (Model 7286) Patients who have been prescribed daily diuretic therapy for the management of heart failure Patients currently participating in the COMPASS-HF Extension Phase Study (IDE #G020304) Patients willing and able to give informed consent Exclusion Criteria: Patients with non-physiologic Right Ventricular (RV) pressure values Patients who have diuretic resistance Patients who have an estimated Glomerular Filtration Rate(eGFR) <30 ml/min (recorded within the last six months) Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303) Patients who do not have the ability to actively participate in the management of their own heart failure care (determine by physician discretion)(e.g. patient does not have ability to operate study equipment, patient does not have a history of compliance to sending CareLink transmissions) Patients who have a reasonable probability of needing a device replacement during the study (approximately two months) Patients enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial Patient who are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Daily diuretic adjustment<br>Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. | Drug: Diuretics<br>* Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cardiac filling pressure