A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tufts Medical Center
Study ID
NCT05627440
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ensure Max Protein — DIETARY_SUPPLEMENT
    Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
  • Ensure Original — DIETARY_SUPPLEMENT
    Ensure Original, 1 bottle daily (237 mL), 9 grams protein

Study Details

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.

Key Dates

Start date
Apr 24, 2023
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental arm
    30 g/day protein supplementation (1 Ensure Max Protein® bottle)
  • Active Comparator: Sham comparator arm
    9 g/day protein supplementation (1 Ensure Original® bottle)
  • No Intervention: No intervention arm
    0 g/day protein supplementation (no Ensure bottles)

Primary Outcome Measure

Appendicular Lean Mass (ALM) [ Time Frame: 6 month study visit ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tufts Medical CenterBostonMassachusetts02111
Olivia Lovegreen
[email protected]
617-636-5000
Indranee N Rajapreyar, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Teresa Fonk
Amanda R Vest, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Tufts Medical Center· Boston, MACleveland Clinic· Cleveland, OH

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