PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Recruiting now · Not applicable
Conditions studied: Heart Failure With Reduced Ejection Fraction
In brief
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).
Key facts
- Study ID
- NCT05609097
- Run by
- University of Virginia
- People needed
- 92
- Starts
- 2023-04-14
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2025-06-06
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- Subjects may be of either sex with age > 65 years.
- Subjects must be diagnosed with HFrEF as per established echocardiographic criteria (New York Heart Association Class II-III) with an ejection fraction <45%.
- Cardiologist approve after thorough chart review and physical examination
- Hemoglobin of at least 10.0 g/dL
You may not qualify if…
- Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days
- Significant ischemia at low exercise intensities (<2 METS or \~50 W)
- Uncontrolled diabetes (HbA1c >10%)
- Acute systemic illness of fever
- Recent embolism (in the 6 weeks)
- Deep Vein Thrombophlebitis
- Active pericarditis or myocarditis
- Severe aortic stenosis (aortic valve area <1.0 cm2)
- Regurgitant valvular heart disease requiring surgery
- Myocardial infarction within previous 3 weeks
- New onset atrial fibrillation (in the last 4 weeks)
- Resting Heart Rate >120bpm
Where it is running
- University of Virginia, Department of Kinesiology — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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