Cardiac Pacing for Heart Failure (HeartExcel Trial)

N/A

Recruiting

Research Sponsored by Denice Hodgson-Zingman, MD

Eligibility Criteria Checklist

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

Must have

Age 18 years or greater

Left ventricular ejection fraction < or = 35% despite at least 3 months guideline-directed medial therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.

Summary

This trial will study the effects of using a heart rate acceleration method through cardiac pacing on subjects with severe heart dysfunction. The goal is to see if this method can have similar effects to traditional exercise and if

Who is the study for?

This trial is for adults over 18 with severe left ventricular dysfunction who have had an implantable cardioverter defibrillator for more than 3 months. They should be experiencing mild to moderate heart failure symptoms despite treatment and must commit to the study schedule.

What is being tested?

The trial tests if a special type of cardiac pacing that mimics exercise can improve heart function in people at rest, compared to a sham (fake) procedure. Participants will receive their assigned intervention three times weekly for six weeks and be monitored up to one year.

What are the potential side effects?

Potential side effects are not explicitly listed, but may include discomfort or complications related to the pacing procedure, changes in heart rhythm, or other issues associated with device manipulation.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My heart's pumping ability is reduced despite 3 months of treatment.

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I experience moderate to severe symptoms of heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in left ventricular ejection fraction by echocardiogram

Secondary study objectives

6-minute walk distance

Cardiopulmonary exercise test maximum oxygen consumption

Cardiopulmonary exercise test metabolic equivalents achieved

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Exercise-similar cardiac pacingExperimental Treatment1 Intervention

Atrial pacing to replicate exercise heart rate envelope once daily, 3 days per week, over 6 weeks while symptoms and vital signs are monitored and outcome measures assessed.

Group II: Sham cardiac pacingPlacebo Group1 Intervention

Sham pacing to replicate exercise heart rate envelope once daily, 3 days per week, over 6 weeks while symptoms and vital signs are monitored and outcome measures assessed.

0 / 3Eligibility criteria met