Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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 Sodium/glucose cotransporter-2 inhibitors (SGLT2i) therapy.

V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m².

Disqualifiers

Unable or unwilling to undergo contrast MRI.

Class I indication for permanent pacing, except for symptomatic chronotropic incompetence

Current permanent or persistent Atrial fibrillation (A-fib)

Structural heart disease requiring intervention

Trial design

Treatments tested in this trial

  • Pacemaker PLR + TRT ON
  • Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

Treatment groups

105 Participants
are divided into 2 treatment groups

Locations

8
Florida
NCH Heart Institute34102, Naples United States
Illinois
Prairie Education and Research Cooperative-St. Elizabeth's62269, O'Fallon United States
Prairie Education and Research Cooperative-St. John's62769, Springfield United States
Kansas
University of Kansas Medical Center66160, Kansas City United States

Sponsors and collaborators

Medtronic Cardiac Rhythm and Heart Failure

Lead sponsor

Source ClinicalTrials.gov