Actively Recruiting
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Led by University of Virginia · Updated on 2025-06-06
92
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).
CONDITIONS
Official Title
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate clearly and give written informed consent
- Age over 65 years
- Diagnosed with heart failure with reduced ejection fraction (HFrEF) and New York Heart Association Class II-III with ejection fraction less than 45%
- Approved by a cardiologist after medical review and physical exam
- Hemoglobin level of at least 10.0 g/dL
You will not qualify if you...
- Worsening exercise tolerance or shortness of breath at rest or with exertion in the past 3-5 days
- Significant ischemia at low exercise intensities
- Uncontrolled diabetes with HbA1c over 10%
- Acute illness with fever
- Recent embolism within the last 6 weeks
- Deep vein thrombophlebitis
- Active pericarditis or myocarditis
- Severe aortic stenosis with valve area less than 1.0 cm2
- Valvular heart disease needing surgery
- Heart attack within the last 3 weeks
- New onset atrial fibrillation within the past 4 weeks
- Resting heart rate over 120 beats per minute
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia, Department of Kinesiology
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
B
Ben Stephenson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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