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Exercise Program for Heart Failure

N/A
Recruiting
Led By Jason Allen, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction <40%.
Must not have
Severe aortic stenosis (aortic valve area <1.0 cm2)
Regurgitant valvular heart disease requiring surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40- weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if PRIME, an aerobic & resistance exercise program, is better than traditional exercise for people with heart failure. Participants will be randomly assigned one.

Who is the study for?
This trial is for individuals over 65 with heart failure and reduced ejection fraction (HFrEF), specifically those who can communicate well, have cardiologist approval, and a hemoglobin level of at least 10.0 g/dL. It's not for people with uncontrolled diabetes, recent heart attacks or embolism, severe valve disease needing surgery, new atrial fibrillation, worsening symptoms in the past few days, significant ischemia during low exercise levels, or certain other acute conditions.
What is being tested?
The study compares a novel exercise program called PRIME against the traditional COMBO exercise regimen to see which one leads to better health outcomes for older patients with HFrEF. Participants will be randomly assigned to either the investigational PRIME program or the standard COMBO training.
What are the potential side effects?
While specific side effects are not listed for these interventions since they involve physical exercise programs rather than drugs; general risks may include muscle soreness, fatigue after exercising and potential exacerbation of existing cardiac conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and communicate about the study, and I can legally consent.
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My heart's pumping ability is weak, and I have moderate heart failure symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe narrowing of my aortic valve.
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I need surgery for a heart valve problem causing backflow.
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I was diagnosed with atrial fibrillation in the last 4 weeks.
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My ability to exercise or breathe has gotten worse in the last 3-5 days.
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I have deep vein thrombosis.
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I have not had a heart attack in the last 3 weeks.
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I currently have a fever due to an illness.
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I do not have active inflammation of the heart.
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My diabetes is not under control (HbA1c over 10%).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40- weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40- weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
VO2peak
Secondary study objectives
Muscular fitness
Physical Function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PRIME + COMBOExperimental Treatment2 Interventions
PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.
Group II: COMBO onlyExperimental Treatment1 Intervention
4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,802 Previous Clinical Trials
28,193,889 Total Patients Enrolled
43 Trials studying Heart Failure
213,388 Patients Enrolled for Heart Failure
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,026 Total Patients Enrolled
35 Trials studying Heart Failure
7,774 Patients Enrolled for Heart Failure
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,354 Total Patients Enrolled
12 Trials studying Heart Failure
1,483 Patients Enrolled for Heart Failure
Jason Allen, PhDPrincipal InvestigatorUniversity of Virginia
3 Previous Clinical Trials
85 Total Patients Enrolled

Media Library

PRIME + COMBO Clinical Trial Eligibility Overview. Trial Name: NCT05609097 — N/A
Heart Failure Research Study Groups: PRIME + COMBO, COMBO only
Heart Failure Clinical Trial 2023: PRIME + COMBO Highlights & Side Effects. Trial Name: NCT05609097 — N/A
PRIME + COMBO 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609097 — N/A
~49 spots leftby Nov 2026
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