Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Medtronic Cardiac Rhythm and Heart Failure

Summary

FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.

Description

After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. After 6 weeks, subjects will have a follow up visit with a blood draw and a cardiac MRI. At this visit, subjects will be randomized 2:1 for pacing therapy or as a control (programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest). After 3, 6 and 9 months after randomization, subjects will return for a follow up visit. At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment: pacing therapy…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (this and other measurements must be made within the last year). * New York Heart Association (NYHA) Functional Class I-III * Stable on guideline-directed medical therapy (GDMT) heart failure medications as determined by the investigator, for at least 1 month, with the exception of loop diuretic therapy. GDMT should be in accordance with current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines and include consideration of Sod…

Interventions

Device
Pacemaker PLR + TRT ON
RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON
Device
Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
RAMware modified implantable pulse generator (IPG)

Locations (8)

NCH Heart Institute
Naples, Florida
Prairie Education and Research Cooperative-St. Elizabeth's
O'Fallon, Illinois
Prairie Education and Research Cooperative-St. John's
Springfield, Illinois
University of Kansas Medical Center
Kansas City, Kansas
Duke University
Durham, North Carolina
Oklahoma Heart Hospital
Oklahoma City, Oklahoma