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
244 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
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.
CONDITIONS
Official 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%, NYHA class II to IV symptoms, or NT-proBNP >300 pg/mL
- Age between 18 and 100 years, inclusive
- Receiving guideline-directed medical therapy (GDMT), unless contraindicated or not tolerated
- At least one marker of severe heart failure within the past 12 months, such as inotropic therapy, heart failure hospitalizations, LVEF ≤ 25%, low peak oxygen consumption, reduced 6-minute walk distance, unintentional weight loss >5%, moderate to severe muscle wasting, or NT-proBNP ≥ 900 pg/mL
You will not qualify if you...
- Pregnancy, planning pregnancy, or women of reproductive potential unwilling to complete pregnancy test before study procedures
- History of left ventricular assist device (LVAD), heart transplantation, or very low kidney function (eGFR < 20 mL/min/1.73 m2)
- Clinical disorders causing muscle weakness or wasting, such as muscular dystrophy, mitochondrial disorders, active cancer, or severe disability after stroke
- Allergies or intolerance to milk, protein, lactose, or galactose
- Weight over 350 pounds and/or BMI of 40 kg/m2 or higher
- Starting or planning to start 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here