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NCT05627440 · ClinicalTrials.gov registry record · NA
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
A NA study of Heart Failure and Muscle Atrophy, sponsored by Tufts Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT05627440: Recruiting NA study of Heart Failure and Muscle Atrophy, sponsored by Tufts Medical Center.
NCT05627440 is a NA study of Heart Failure and Muscle Atrophy that is actively recruiting participants, run by Tufts Medical Center. The registered enrollment target is 120 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05627440, a NA study of Heart Failure and Muscle Atrophy, is actively recruiting participants, sponsored by Tufts Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.
Primary Outcome
ALM as measured by dual X-ray absorptiometry (DXA)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ensure Max Protein
- DIETARY_SUPPLEMENT Ensure Original
Study Locations (2)
Massachusetts
- Tufts Medical Center - Boston
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT05627440 shows while recruiting
NCT05627440 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Ensure Max Protein is the first listed.
NCT05627440 reports a single indexed study location in Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT05627440 about?
NCT05627440 is a clinical study titled "A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure". Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF ...
What is the current status of trial NCT05627440?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-04-24. Estimated completion is 2027-12-31.
What conditions does trial NCT05627440 study?
This clinical trial studies the following conditions: Heart Failure, Muscle Atrophy.
What interventions are being tested in trial NCT05627440?
The interventions under investigation include: Ensure Max Protein (DIETARY_SUPPLEMENT), Ensure Original (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05627440?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627440 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
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 NCT05627440's enrollment target sits among peer trials
120 202nd of 397 higher than 194 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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