AzTrials
AzTrials

Heart Failure With Preserved Ejection FractionFIRE-HFpEFNCT05839730

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

A study testing Pacemaker PLR + TRT ON and Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest. in people with Heart Failure With Preserved Ejection Fraction and Concentric Hypertrophy, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pacemaker PLR + TRT ON and Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
8 sitesUnited States
Study dates
11 Sep 2024to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Duke University

    Durham, North Carolina, 27708

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • NCH Heart Institute

    Naples, Florida, 34102

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

    O'Fallon, Illinois, 62269

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

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

    Springfield, Illinois, 62769

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pacemaker PLR + TRT ON, Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pacemaker PLR + TRT ONDevice

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

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

    RAMware modified implantable pulse generator (IPG)

Study groups in NCT05839730
Study groupRoleWhat they receive
Pacemaker with multiple pacing therapies enabledExperimentalDevice will be programmed for personalized lower rate pacing (PLR) and tachycardiac remodeling pacing (TRT).
Receives: Device: Pacemaker PLR + TRT ON
Pacemaker with no pacing therapies enabledActive comparatorDevice will be programmed to a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
Receives: Device: Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start11 Sep 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839730
Sponsor's protocol ID
MDT20060
Acronym
FIRE-HFpEF
Status last verified
Oct 2026
First submitted
1 Mar 2023
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pacemaker PLR + TRT ON and Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest. in people with Heart Failure With Preserved Ejection Fraction and Concentric Hypertrophy, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Through study completion, projected for three years until last subject last 12-month visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05839730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in