Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Last updated: April 24, 2025
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Pacemaker PLR + TRT ON

Pacemaker PLR ON

Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

Clinical Study ID

NCT05839730
MDT20060
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Heart Failure, Left Ventricular Ejection Fraction (LVEF) ≥ 55% (thisand 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 asdetermined by the investigator, for at least 1 month, with the exception of loopdiuretic therapy. GDMT should be in accordance with current American HeartAssociation (AHA)/American College of Cardiology (ACC)/Heart Failure Society ofAmerica (HFSA) Guidelines and include consideration of Sodium/glucosecotransporter-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 thefollowing 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

Exclusion

Exclusion Criteria:

  • Unable or unwilling to undergo contrast MRI.

  • Class I indication for permanent pacing, except for symptomatic chronotropicincompetence

  • Current permanent or persistent Atrial fibrillation (A-fib)

  • Structural heart disease requiring intervention

  • Aortic valve replacement procedure less than 12 months prior to enrollment

  • Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrativecardiomyopathy

  • Severe aortic or mitral valve disease, defined as severe regurgitation or a valvearea < 1cm^2

  • Exertional angina

  • Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebulizer therapy, or chronic oralsteroid therapy or hospitalized for pulmonary decompensation within 12 months)

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

  • Uncontrolled blood pressure, defined as systolic pressure outside the range of 100to 160 mmHg despite anti-hypertensive medication.

Study Design

Total Participants: 105
Treatment Group(s): 3
Primary Treatment: Pacemaker PLR + TRT ON
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
January 31, 2026

Study 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 will be terminated in the original therapy group and enabled in the control group. After an additional 3-months of follow-up, subjects will return for their final visit, therapies will be disabled in all subjects and subjects will be exited. Echocardiographic, functional, and health status endpoints will be collected and analyzed to assess therapy efficacy.

Connect with a study center

  • NCH Heart Institute

    Naples, Florida 34102
    United States

    Active - Recruiting

  • AdventHealth CV Research Institute

    Orlando, Florida 32746
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Prairie Education and Research Cooperative-St. Elizabeth's

    O'Fallon, Illinois 62269
    United States

    Site Not Available

  • Prairie Education and Research Cooperative

    Springfield, Illinois 62769
    United States

    Active - Recruiting

  • Prairie Education and Research Cooperative-St. John's

    Springfield, Illinois 62769
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27708
    United States

    Active - Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Dallas VA Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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