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

Launched by UNIVERSITY OF VIRGINIA · Nov 1, 2022

Keywords

ClinConnect Summary

The PRIME HFrEF clinical trial is investigating a new exercise program designed for older patients with heart failure that involves both aerobic and resistance training. This program, known as PRIME (Peripheral Remodeling via Intermittent Muscular Exercise), will be compared to a traditional exercise program called COMBO, which is commonly used for people with heart failure with reduced ejection fraction (HFrEF). Participants in the study will be randomly assigned to either the new PRIME program or the standard COMBO program to see which one leads to better health outcomes.

To join the trial, participants must be at least 65 years old, be able to communicate clearly, and have a diagnosis of heart failure with reduced ejection fraction (with an ejection fraction below 40%). Participants will be closely monitored throughout the study, and they should feel comfortable discussing their health with the research team. It’s important to note that certain health conditions or recent medical events may exclude someone from participating. This trial aims to provide new insights into how exercise can benefit older adults with heart failure, potentially improving their quality of life.

Gender

ALL

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