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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05627440
The ClinicalTrials.gov registry entry for NCT05627440 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (94% lower). The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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