PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Recruiting · NCT05609097 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
COMBOPRIME
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).
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 \<45%.
- Cardiologist approve after thorough chart review and physical examination
- Hemoglobin of at least 10.0 g/dL
Exclusion criteria
- 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
1 location listed across 1 US state.
- University of Virginia, Department of Kinesiology - Charlottesville, Virginia, United States