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A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Study acronym: ASTRID-HF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 31, 2027 to Jun 1, 2027v11
  2. Eligibility criteria expanded, about 27 words Site contacts updated at 2 of 2 sitesv10 Show 1 more changeShow less
    • Site contacts updated at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site contacts updated at 2 of 2 sites Eligibility criteria expanded, about 4 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 1 of 2 sitesv8
  5. Study sites: 1 to 2v7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria expanded, about 7 wordsv6 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 21, 2023 to Apr 24, 2023 · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 1 of 9 entries · 1 morev5 Show 4 more changesShow less
    • Start date changed from estimate of Apr 21, 2023 to Apr 24, 2023
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Dec 31, 2025 to Jan 31, 2027 Completion date: Dec 31, 2026 to Dec 31, 2027 · Start date: Apr 3, 2023 to Apr 21, 2023v4 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Dec 31, 2027
    • Start date: Apr 3, 2023 to Apr 21, 2023
  4. Eligibility criteria expanded, about 24 wordsv3 See this version in full on ClinicalTrials.gov ↗
  5. Start date: Jan 16, 2023 to Apr 3, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05627440
Lead Sponsor Tufts Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Heart Failure, Muscle Atrophy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov