NCT05609097Recruiting
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 1 Nov 2022
- Start date
- 14 Apr 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Virginia
- Diseases
- Heart failure
- NCT number
- NCT05609097
What you commit to
- Study type: Interventional
- Planned participants: 92
- From 14 Apr 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days
- Myocardial infarction within previous 3 weeks
Other illness
- Acute systemic illness of fever
- Regurgitant valvular heart disease requiring surgery
- Resting Heart Rate \>120bpm
Lab values
- Uncontrolled diabetes (HbA1c \>10%)
Other
- Significant ischemia at low exercise intensities (\<2 METS or \~50 W)
- Recent embolism (in the 6 weeks)
- Deep Vein Thrombophlebitis
- Active pericarditis or myocarditis
- Severe aortic stenosis (aortic valve area \<1.0 cm2)
- New onset atrial fibrillation (in the last 4 weeks)
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia, Department of Kinesiology Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.