Heart Failure Clinical Trial
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
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).
This study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (COMBO) or PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO assigned to all participants (Phase 2). The objective of this study is to determine whether PRIME exercise training can outperform traditional (COMBO) exercise training to improve outcomes in HFrEF patients. The study aims to test 92 HFrEF patients (46 randomized to PRIME and 46 to COMBO training) over a 5-year period. Data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit.
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 <40%.
Cardiologist approve after thorough chart review and physical examination
Hemoglobin of at least 10.0 g/dL
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
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There is 1 Location for this study
Charlottesville Virginia, 22908, United States More Info
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