A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

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) >300pg/mL

2. Age 18 years to 100 years, inclusive

3. Receiving guideline-directed medical therapy (GDMT), unless contraindicated or nottolerated

4. Any of the following markers of severe HF within prior 12 months: i) Inotropictherapy; ii) 1 or more HF hospitalizations; iii) LVEF ≤25%; iv) Peak oxygenconsumption (VO2) <50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance <300meters; vi) Unintentional weight loss >5% of bodyweight over the past year; vii)Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900pg/mL

Exclusion Criteria:

1. Pregnancy, planning to become pregnant, or women of reproductive potential unwillingto complete pre-DXA urine pregnancy test before first DXA or randomization

2. History of left ventricular assist device (LVAD), heart transplantation, orestimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2

3. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankinscore greater or equal to 4 post-stroke)

4. Milk allergy, protein allergy, lactose intolerance, and galactosemia

5. Weight ≥350 pounds and/or BMI ≥40 kg/m2

6. Initiation of obesity-dosed GLP-1 or GIP/GLP-1 agonist within 3 months prior toscreening, or clinical intention to begin such an anti-obesity medication within thenext 6 months.