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

University of Virginia

Status: Enrolling

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: COMBO; Other: PRIME

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05609097

1R01AG075556-01A1 (U.S. NIH Grant/Contract)

HSR220112

Details and patient eligibility

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).

Full description

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

PRIME + COMBO

Experimental group

Description:

PRIME training (Phase 1), followed by 8 weeks of progressive whole-body COMBO training.

Treatment:

Other: PRIME

Other: COMBO

COMBO only

Other group

Description:

4 weeks of standard progressive whole-body aerobic plus resistance training (COMBO) followed by 8 weeks continued COMBO training.

Treatment:

Other: COMBO