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NCT05839730Active, not recruiting

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
105 (estimated)
First submitted
1 Mar 2023
Start date
11 Sept 2024
Primary completion date
Sept 2027
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
NCT number
NCT05839730

What you commit to

  • Study type: Interventional
  • Planned participants: 105
  • From 11 Sept 2024 to the primary completion date, Sept 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Aortic valve replacement procedure less than 12 months prior to enrollment
  • Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.

Other illness

  • Structural heart disease requiring intervention
  • Severe aortic or mitral valve disease, defined as severe regurgitation or a valve area \< 1cm\^2
  • Exertional angina
  • Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalized for pulmonary decompensation within 12 months)

Lab values

  • Estimated glomerular filtration rate (eGFR) \< 25 ml/min/1.73m\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula

Other

  • 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)
  • Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy

Who the study is looking for

  • 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/m\^2.
  • Concentric remodeling or concentric hypertrophy defined as at least one of the following criteria:
    • Left ventricular (LV) posterior or lateral wall thickness \> 11mm
    • Relative wall thickness (RWT) \> 0.42
    • Male and LV mass indexed to BSA ≥115 g/m2
    • Male and LV mass indexed to height ≥ 49.2 g/m2.7
    • Female and LV mass indexed to BSA ≥ 95 g/m2
    • Female and LV mass indexed to height ≥ 46.7 g/m2.7

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Vermont Medical Center
Coordinator of this site? Confirm its status
BurlingtonUnited StatesUnknown status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Houston Methodist Research Institute
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
NCH Heart Institute
Coordinator of this site? Confirm its status
NaplesUnited StatesUnknown status
Prairie Education and Research Cooperative-St. Elizabeth's
Coordinator of this site? Confirm its status
O'FallonUnited StatesUnknown status
Oklahoma Heart Hospital
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Prairie Education and Research Cooperative-St. John's
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.