RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 \<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

Study sites (1)

VA