CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Diureticsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01370564
NCT01370564Phase 2Completed
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Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Jun 10, 2011·Updated Jul 11, 2018

In Brief

A Phase 2 clinical trial evaluating Diuretics for Heart Failure. Completed, enrolled 21 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2011
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.1 years ago

Interventions

Diureticsdrug

Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.