Overview

This trial is active, not recruiting.

Condition heart failure
Treatment diuretics
Phase phase 2
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date June 2011
End date February 2012
Trial size 21 participants
Trial identifier NCT01370564, IPC

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.

Primary Outcomes

Measure
Characterize the technical feasibility of the network based IPC system
time frame: Baseline through Completion/Exit

Secondary Outcomes

Measure
Characterize the rate of IPC setup system changes
time frame: Baseline through Completion/Exit
Quantify subject compliance to daily PtIS
time frame: Baseline through Completion/Exit
Estimate changes in clinical markers of heart failure and kidney function
time frame: Baseline through Completion/Exit
Summarize adverse events
time frame: Baseline through Completion/Exit

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Principal investigator Philip Adamson, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.