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Recruiting NCT05609097

PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction

Conditions: Heart Failure With Reduced Ejection Fraction

Sex: All
Ages: 65 Years – N/A
Phase: NA
Enrollment: 92
Sponsor: University of Virginia

Location: United States

Summary

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).

Eligibility Criteria

Inclusion Criteria: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 examinationHemoglobin of at least 10.0 g/dLExclusion Criteria:Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 daysSignificant ischemia at low exercise intensities (<2 METS or ~50 W)Uncontrolled diabetes (HbA1c >10%)Acute systemic illness of feverRecent embolism (in the 6 weeks)Deep Vein ThrombophlebitisActive pericarditis or myocarditisSevere aortic stenosis (aortic valve area <1.0 cm2)Regurgitant valvular heart disease requiring surgeryMyocardial infarction within previous 3 weeksNew onset atrial fibrillation (in the last 4 weeks)Resting Heart Rate >120bpm

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05609097). StuddyBuddy aggregates publicly available trial information.