Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction

Description

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.

Conditions

Heart Failure with Preserved Ejection Fraction, Concentric Hypertrophy

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Study Overview

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Study Details

Study overview

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.

Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction

Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction

Condition
Heart Failure with Preserved Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Naples

NCH Heart Institute, Naples, Florida, United States, 34102

Springfield

Prairie Education and Research Cooperative, Springfield, Illinois, United States, 62769

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Durham

Duke University, Durham, North Carolina, United States, 27708

Oklahoma City

Oklahoma Heart Hospital, Oklahoma City, Oklahoma, United States, 73120

Dallas

Dallas VA Medical Center, Dallas, Texas, United States, 75216

Houston

Houston Methodist Research Institute, Houston, Texas, United States, 77030

Burlington

The University of Vermont Medical Center, Burlington, Vermont, United States, 05401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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
  • * Aortic valve replacement procedure less than 12 months prior to enrollment
  • * Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
  • * 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)
  • * Estimated glomerular filtration rate (eGFR) \< 25 ml/min/1.73m\^2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula
  • * Uncontrolled blood pressure, defined as systolic pressure outside the range of 100 to 160 mmHg despite anti-hypertensive medication.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiac Rhythm and Heart Failure,

Study Record Dates

2026-01