Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

NCT05839730 | Recruiting FDA Device

• 1 other identifier: MDT20060
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 8

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Concentric Hypertrophy

Outcome Measures

Primary Outcomes (3)

• characterize the effect of TRT + PLR on cardiac structure. LV mass, LVEDV, LVESV, and wall thickness which will be collected at baseline, 3-month, 6-month, 9-month, and 12-month visits.

  Through study completion, projected for three years until last subject last 12-month visit.

• Characterize the effect of pacing therapies on health status, defined as change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 3, 6, and 9 months.

  The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life. Each of the 21 questions are scored on a 6-point Likert Scale (0 to 5), the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.

  Through study completion, projected for three years until last subject last 12-month visit.

• Characterize the durability of cardiac remodeling changes and assess the safety and tolerability of TRT + PLR.

  Through study completion, projected for three years until last subject last 12-month visit.

Study Arms (2)

Pacemaker with multiple pacing therapies enabled

EXPERIMENTAL

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

Device: Pacemaker PLR + TRT ON

Pacemaker with no pacing therapies enabled

ACTIVE COMPARATOR

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

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

Interventions

Pacemaker PLR + TRT ON DEVICE

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

Pacemaker with multiple pacing therapies enabled

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

RAMware modified implantable pulse generator (IPG)

Pacemaker with no pacing therapies enabled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

NCH Heart Institute

Naples, Florida, 34102, United States

RECRUITING

Prairie Education and Research Cooperative-St. Elizabeth's

O'Fallon, Illinois, 62269, United States

RECRUITING

Prairie Education and Research Cooperative-St. John's

Springfield, Illinois, 62769, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Central Study Contacts

Scott A Sarazin

CONTACT

763-526-2817; scott.a.sarazin@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects and assessors of outcomes will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects will have enrollment data collected, including a blood draw. 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.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: May 3, 2023
• Study Start: September 11, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)