Pacemaker Therapy for Heart Failure (FIRE-HFpEF Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with heart failure who still have normal or near-normal heart pumping function (LVEF ≥ 55%), specifically those in NYHA Functional Class I-III without severe symptoms. Participants should show signs of a thickened heart muscle and be stable on standard heart failure meds, except diuretics, for at least a month. They can't join if they need a pacemaker for other reasons, have severe chest pain during exercise, permanent A-fib, recent valve surgery, serious lung disease like COPD, very low kidney function (eGFR < 25), uncontrolled high blood pressure despite treatment, or certain types of cardiomyopathy.

Inclusion Criteria

My heart's size is within the normal range for my body size.

My heart condition allows me to perform daily activities with minimal to moderate difficulty.

Exclusion Criteria

I experience chest pain when I exert myself.

I have severe lung disease such as advanced COPD.

I had an aortic valve replacement less than a year ago.

I have severe heart valve disease.

I cannot or do not want to have an MRI with contrast.

I have ongoing A-fib.

My blood pressure is not controlled by medication and is outside 100-160 mmHg.

I have a specific heart condition like thickened heart walls or abnormal heart muscle.

I need treatment for a heart condition.

Treatment Details

The FIRE-HFpEF study is testing whether special pacing therapies from pacemakers can improve the ability to exercise and overall health in patients with Heart Failure with Preserved Ejection Fraction (HFpEF). It's comparing two different pacemaker settings to see which might work better. Up to 105 participants will be randomly assigned to one of these treatments at multiple centers.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pacemaker with multiple pacing therapies enabledExperimental Treatment1 Intervention

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

Group II: Pacemaker with no pacing therapies enabledActive Control1 Intervention

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