Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT05839730

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2027-07-31

Brief 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.

Detailed 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.

Conditions

Heart Failure With Preserved Ejection Fraction; Concentric Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pacemaker with multiple pacing therapies enabled

Device will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).

Group Type: EXPERIMENTAL

Pacemaker PLR + TRT ON

Intervention Type: DEVICE

RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON

Pacemaker with no pacing therapies enabled

Device will be programmed to a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

RAMware modified implantable pulse generator (IPG)

Interventions

Pacemaker PLR + TRT ON

RAMware modified implantable pulse generator (IPG) with personalized lower rate (PLR) and tachycardia remodeling therapy (TRT) ON

Intervention Type: DEVICE

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

RAMware modified implantable pulse generator (IPG)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NCH Heart Institute

Naples, Florida, United States

Site Status: RECRUITING

Prairie Education and Research Cooperative-St. Elizabeth's

O'Fallon, Illinois, United States

Site Status: RECRUITING

Prairie Education and Research Cooperative-St. John's

Springfield, Illinois, United States

Site Status: RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Dallas VA Medical Center

Dallas, Texas, United States

Site Status: NOT_YET_RECRUITING

Houston Methodist Research Institute

Houston, Texas, United States

Site Status: RECRUITING

The University of Vermont Medical Center

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Scott A Sarazin

Role: CONTACT

scott.a.sarazin@medtronic.com

763-526-2817

Facility Contacts

Dinesh Sharma, MD

Role: primary

Ziad Issa, MD

Role: primary

Ziad Issa, MD

Role: primary

Seth Sheldon, MD

Role: primary

Daniel Friedman, MD

Role: primary

Charles Te, MD

Role: primary

Phi Wiegn, MD

Role: primary

Miguel Valderrabano, MD

Role: primary

Nicole Habel, MD

Role: primary

Other Identifiers

MDT20060

Identifier Type: -

Identifier Source: org_study_id