NCT01370564

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Diuretics	Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2011-06-10
• Last updated: 2018-07-11
• Results posted: 2018-07-11

Locations

3 sites across 1 country: United States