NCT05627440

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Muscle Atrophy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-24
• Primary completion: 2027-06-01
• Completion: 2027-12-31
• First posted: 2022-11-25
• Last updated: 2025-11-25

Locations

2 sites across 1 country: United States