Actively Recruiting
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Led by Tufts Medical Center · Updated on 2025-11-25
120
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
Tufts Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study muscle loss in patients with heart failure with reduced ejection fraction (HFrEF), a condition where the heart does not pump blood effectively. It focuses on severe muscle wasting and weight loss common in these patients. The trial will explore whether increasing dietary protein intake can help reverse muscle loss, and it also examines biological pathways like GDF-15 and ActRII that may drive this muscle wasting. Participants will be randomly assigned to one of three groups receiving different levels of protein supplementation using Ensure products by Abbott Nutrition. One group receives a high dose of 30 grams protein daily (Ensure Max Protein), another a low dose of 9 grams protein daily (Ensure Original), and the third group receives no supplementation. The intervention lasts for 6 months with monitoring at 3 and 6 months. During the study, participants will have their muscle mass measured in arms and legs (appendicular lean mass) at 3 and 6 months. Additional assessments include handgrip strength, walking ability with a 6-minute walk test, and physical performance tests. Researchers will monitor protein intake and evaluate safety throughout the trial, which is sponsored by Tufts Medical Center and runs up to 2027.
CONDITIONS
Brief Title
A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left ventricular ejection fraction (LVEF) 40% or less, with NYHA class II to IV symptoms or NT-proBNP greater than 300 pg/mL
- Age between 18 and 100 years, inclusive
- Receiving guideline-directed medical therapy for heart failure, unless contraindicated or not tolerated
- Presence of at least one marker of severe heart failure within the prior 12 months, such as inotropic therapy, heart failure hospitalizations, low peak oxygen consumption, limited 6-minute walk distance, significant unintentional weight loss, moderate or severe muscle wasting, or high NT-proBNP levels
You will not qualify if you...
- Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pregnancy testing before randomization
- History of left ventricular assist device, heart transplantation, or severe kidney impairment (eGFR less than 20 mL/min/1.73 m2)
- Known clinical disorders causing muscle weakness or wasting such as muscular dystrophy, mitochondrial disorders, active cancer, or severe post-stroke disability
- Allergies or intolerances to milk, protein, lactose, or galactose
- Weight over 350 pounds or body mass index over 40 kg/m2
- Recent or planned use of obesity-dosed GLP-1 or GIP/GLP-1 agonist medications within specified timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily protein supplementation with either Ensure Max Protein, Ensure Original, or no supplementation to support muscle recovery in heart failure.
Visits at 3 months and 6 months for assessments
Trial Site Locations
Total: 2 locations
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Amanda R Vest, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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