Dietary protein intervention for muscle recovery in heart failure patients

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

This study is testing if adding more protein to the diet can help heart failure patients keep their muscle mass and recover better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Tufts Medical Center (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05627440 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of dietary protein supplementation on muscle mass in patients with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized into three groups receiving no, low, or high doses of protein supplementation using Ensure products. The study aims to determine if increased dietary protein can help prevent muscle wasting associated with heart failure and to enhance understanding of the biological pathways involved in muscle loss. The trial will measure changes in appendicular lean mass in the arms and legs over the course of the intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 100 with HFrEF and specific markers of severe heart failure.

Not a fit: Patients who are pregnant or have a history of left ventricular assist device or heart transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve muscle mass and overall health outcomes for patients with heart failure.

How similar studies have performed: Previous studies have shown promising results with dietary interventions in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 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
2. Age 18 years to 100 years, inclusive
3. Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
4. 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:

1. Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
2. History of left ventricular assist device (LVAD), heart transplantation, or estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73 m2
3. 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)
4. Milk allergy, protein allergy, lactose intolerance, and galactosemia
5. Weight ≥350 pounds and/or BMI ≥40 kg/m2
6. 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.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Amanda R Vest, MBBS

Conditions: Heart Failure, Muscle Atrophy