A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure
Tufts Medical Center
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
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 we…
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 CenterBoston, Massachusetts
- Cleveland ClinicCleveland, Ohio