RECRUITING

Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction

Conditions

Heart Failure with Preserved Ejection Fraction Concentric Hypertrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Fast Induced Remodeling in Heart Failure with Preserved Ejection Fraction

Quick Facts

Study Start:2024-09-11

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05839730

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Scott A Sarazin

CONTACT

763-526-2817

scott.a.sarazin@medtronic.com

Study Locations (Sites)

NCH Heart Institute

Naples, Florida, 34102

United States

Prairie Education and Research Cooperative

Springfield, Illinois, 62769

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Duke University

Durham, North Carolina, 27708

United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120

United States

Dallas VA Medical Center

Dallas, Texas, 75216

United States

Houston Methodist Research Institute

Houston, Texas, 77030

United States

The University of Vermont Medical Center

Burlington, Vermont, 05401

United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-09-11

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure with Preserved Ejection Fraction
Concentric Hypertrophy