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Pacemaker Therapy

Pacemaker Therapy for Heart Failure (FIRE-HFpEF Trial)

N/A

Waitlist Available

Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

V End Diastolic Volume indexed to body surface area (BSA) ≤ 80 mL/m^2

New York Heart Association (NYHA) Functional Class I-III

Must not have

Exertional angina

Severe pulmonary disease including severe Chronic obstructive pulmonary disease (COPD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, projected for three years until last subject last 12-month visit.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if treatments like pacing can improve exercise capacity & health status for people with Heart Failure & Preserved Ejection Fraction.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with pacemaker implantation may include infection at the site of implantation, bleeding or bruising around the area where it was placed under the skin; discomfort or swelling; potential lead displacement; and rarely more serious complications such as damage to nearby structures including nerves or blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience chest pain when I exert myself.

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I have severe lung disease such as advanced COPD.

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

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I have severe heart valve disease.

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

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I have ongoing A-fib.

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

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

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I need treatment for a heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, projected for three years until last subject last 12-month visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, projected for three years until last subject last 12-month visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, projected for three years until last subject last 12-month visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Characterize durability of changes in cardiac structure and/or health & functional status following the modification or cessation of pacing therapies at 7, 10, and 12 months.

Characterize the impact of AVNS therapy on changes in serum biomarkers: Tumor Necrosis Factor (TNF-α), Interleukin 6 (IL-6) Interleukin 1 beta (IL-1β) from pre-implant to 0 hours, 4 hours, 24 hours and 6 weeks post-implant.