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Recruiting NCT05627440

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

No phase Interventional Heart Failure Muscle Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ensure Max Protein, Ensure Original.
Who it may be relevant to
Registry conditions: Heart Failure, Muscle Atrophy. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Appendicular Lean Mass (ALM) [Time frame: 6 month study visit]
Secondary outcome measures (9)
  • Appendicular Lean Mass (ALM) [Time frame: 3 month study visit]
  • Protein intake [Time frame: 6 month study visit]
  • Protein intake [Time frame: 3 month study visit]
  • Handgrip strength [Time frame: 6 month study visit]
  • Handgrip strength [Time frame: 3 month study visit]
  • 6-minute walk test (6MWT) [Time frame: 6 month study visit]
  • 6-minute walk test (6MWT) [Time frame: 3 month study visit]
  • Short physical performance battery (SPPB) [Time frame: 6 months]
  • Short physical performance battery (SPPB) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or N-terminal pro B-natriuretic peptide (NT-proBNP) >300 pg/mL
  • Age 18 years to 100 years, inclusive
  • Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
  • Any of the following markers of severe HF within prior 12 months: i) Inotropic therapy; ii) 1 or more HF hospitalizations; iii) LVEF ≤25%; iv) Peak oxygen consumption (VO2) <50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance <300 meters; vi) Unintentional weight loss >5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900 pg/mL

Exclusion criteria

  • Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
  • History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2
  • An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke)
  • Milk allergy, protein allergy, lactose intolerance, and galactosemia
  • Weight ≥350 pounds and/or BMI ≥40 kg/m2
  • Initiation of obesity-dosed GLP-1 or GIP/GLP-1 agonist within 3 months prior to screening, or clinical intention to begin such an anti-obesity medication within the next 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Tufts Medical Center — Boston
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT05627440 · STUDY00003095 · 1R01HL167113-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗