Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
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).
Status | Recruiting |
Enrollment | 92 |
Est. completion date | March 31, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia, Department of Kinesiology | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
Allen JD, Robbins JL, Vanbruggen MD, Credeur DP, Johannsen NM, Earnest CP, Pieper CF, Johnson JL, Church TS, Ravussin E, Kraus WE, Welsch MA. Unlocking the barriers to improved functional capacity in the elderly: rationale and design for the "Fit for Life trial". Contemp Clin Trials. 2013 Sep;36(1):266-75. doi: 10.1016/j.cct.2013.07.007. Epub 2013 Jul 27. — View Citation
Allen JD, Vanbruggen MD, Johannsen NM, Robbins JL, Credeur DP, Pieper CF, Sloane R, Earnest CP, Church TS, Ravussin E, Kraus WE, Welsch MA. PRIME: A Novel Low-Mass, High-Repetition Approach to Improve Function in Older Adults. Med Sci Sports Exerc. 2018 May;50(5):1005-1014. doi: 10.1249/MSS.0000000000001518. — View Citation
Angadi SS, Jarrett CL, Sherif M, Gaesser GA, Mookadam F. The effect of exercise training on biventricular myocardial strain in heart failure with preserved ejection fraction. ESC Heart Fail. 2017 Aug;4(3):356-359. doi: 10.1002/ehf2.12149. Epub 2017 Mar 16. — View Citation
Angadi SS, Mookadam F, Lee CD, Tucker WJ, Haykowsky MJ, Gaesser GA. High-intensity interval training vs. moderate-intensity continuous exercise training in heart failure with preserved ejection fraction: a pilot study. J Appl Physiol (1985). 2015 Sep 15;119(6):753-8. doi: 10.1152/japplphysiol.00518.2014. Epub 2014 Sep 4. — View Citation
Rickli H, Kiowski W, Brehm M, Weilenmann D, Schalcher C, Bernheim A, Oechslin E, Brunner-La Rocca HP. Combining low-intensity and maximal exercise test results improves prognostic prediction in chronic heart failure. J Am Coll Cardiol. 2003 Jul 2;42(1):116-22. doi: 10.1016/s0735-1097(03)00502-3. — View Citation
Shoemaker MJ, Curtis AB, Vangsnes E, Dickinson MG. Triangulating Clinically Meaningful Change in the Six-minute Walk Test in Individuals with Chronic Heart Failure: A Systematic Review. Cardiopulm Phys Ther J. 2012 Sep;23(3):5-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2peak | Change in cardiorespiratory fitness (peak oxygen consumption [V?O2peak]) after 12 weeks of training. The primary null hypothesis will test if mean change in V?O2peak after 12 weeks of training is the same for subjects who initially undergo 4 weeks of PRIME before undergoing 8 weeks of progressive whole-body COMBO, versus subjects who undergo the whole 12 weeks of progressive COMBO. The alternative hypothesis is that the mean change in V?O2peak after 12 weeks of training is not the same for subjects who initially undergo 4 weeks of PRIME training before undergoing 8 weeks of progressive COMBO, versus subjects who undergo the whole 12 weeks of progressive COMBO. Secondary endpoints include blood pressure, vascular function [arterial stiffness, endothelial function (FMD)] muscle characteristics and histochemistry, blood chemistry, physical fitness testing, quality of life questionnaires, and adherence. | 12 weeks | |
Secondary | Muscular fitness | Evaluated using 1 repetition maximal strength [1RM] measured in kg units | 40- weeks | |
Secondary | Physical Function | Evaluated by the Senior Fitness Test scores [SFT], measured in percentile units. | 40- weeks |
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