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NCT05609097 · ClinicalTrials.gov registry record · NA
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
A NA study of Heart Failure With Reduced Ejection Fraction, sponsored by University of Virginia.
- Recruiting
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT05609097: Recruiting NA study of Heart Failure With Reduced Ejection Fraction, sponsored by University of Virginia.
NCT05609097 is a NA study of Heart Failure With Reduced Ejection Fraction that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 92 participants, below the 3,962-participant average among 27 other Heart Failure With Reduced Ejection Fraction trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05609097, a NA study of Heart Failure With Reduced Ejection Fraction, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
Change in cardiorespiratory fitness (peak oxygen consumption \[V̇O2peak\]) after 12 weeks of training. The primary null hypothesis will test if mean change in V̇O2peak 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 V̇O2peak after 12 weeks of training is not the same for sub
Conditions Studied
Interventions
- OTHER PRIME
- OTHER COMBO
Study Locations (1)
Virginia
- University of Virginia, Department of Kinesiology - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2023-04-14 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
What NCT05609097 shows while recruiting
NCT05609097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 3,962-participant average among 27 other Heart Failure With Reduced Ejection Fraction trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Heart Failure With Reduced Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which PRIME is the first listed.
NCT05609097 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05609097 about?
NCT05609097 is a clinical study titled "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 individua...
What is the current status of trial NCT05609097?
This trial is currently recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2023-04-14. Estimated completion is 2028-06-30.
What conditions does trial NCT05609097 study?
This clinical trial studies the following conditions: Heart Failure With Reduced Ejection Fraction.
What interventions are being tested in trial NCT05609097?
The interventions under investigation include: PRIME (OTHER), COMBO (OTHER).
Who is sponsoring clinical trial NCT05609097?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05609097 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure With Reduced Ejection Fraction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05609097's enrollment target sits among peer trials
92 17th of 27 higher than 11 of 27 other Heart Failure With Reduced Ejection Fraction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Reduced Ejection Fraction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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