RecruitingNot ApplicableNCT05627440

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure


Sponsor

Tufts Medical Center

Enrollment

120 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a high-protein dietary supplement can help people with heart failure preserve or rebuild their muscle mass. Heart failure often leads to significant muscle loss (called cardiac cachexia), which worsens quality of life and outcomes. The study uses a body composition scan (DXA) to measure muscle changes. **You may be eligible if...** - You are 18 or older with heart failure and a low ejection fraction (reduced pumping function, ≤40%) - You are on optimal heart failure medications - You have had at least one marker of severe heart failure in the past year (such as hospitalization, very low exercise capacity, or significant unintentional weight loss) **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You have had a heart transplant or a ventricular assist device (LVAD) - You have severely reduced kidney function (eGFR below 20) - You have a known muscle-wasting condition unrelated to heart failure (like muscular dystrophy or active cancer) - You have a milk allergy, lactose intolerance, or galactosemia - You have severe obesity (BMI ≥40 or weight above 350 pounds) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEnsure Max Protein

Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein

DIETARY_SUPPLEMENTEnsure Original

Ensure Original, 1 bottle daily (237 mL), 9 grams protein


Locations(2)

Tufts Medical Center

Boston, Massachusetts, United States

Cleveland Clinic

Cleveland, Ohio, United States

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NCT05627440


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