Severe skeletal muscle loss (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 protien 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 advanced understanding of the GDF-15 and ActRII muscle wasting pathways.
ASTRID-HF
A SkeleTal muscle Recovery Intervention with Dietary protein in Heart Failure (ASTRID-HF)
18-100
Overview
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Study details
- 1. Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or 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 HF hospitalizations; iii) LVEF ≤25%; iv) Peak VO2 <50% predicted or ≤16 mL/kg/min; v) 6-minute walk distance <300 meters; vi) Unintentional weight loss >5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination1. Left ventricular ejection fraction (LVEF) ≤40%, New York Heart Association (NHYA) class II to IV symptoms or NT-proBNP >300 pg/mL
- 1. Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pre-DXA urine pregnancy test before first DXA or randomization
2. History of LVAD, heart transplantation, or estimated 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 Rankin score ³4 post-stroke)
- 4. Milk allergy, protein allergy, lactose intolerance, and galactosemia.
5. Weight ≥350 pounds and/or BMI ≥40 kg/m2
This project seeks to understand the nutrition and metabolism abnormalities that occur during skeletal muscle wasting and to specifically determine if oral protein supplementation can help maintain muscle mass and strength. Participants in this study will be randomly assigned between 3 groups for a study period of 6 months, with 2 of the 3 groups receiving differing amounts of protein supplementation daily that is delivered as 1 bottle of an Ensure® shake product per day. There will be research measurements of muscle mass, muscle strength, blood metabolism and nutritional status at baseline, 3 months and 6 months of the study. Each fasting blood sample will be performed for analyses of the hormones and metabolic signals that may affect muscles, totaling approximately 8 teaspoons or 40 ml of blood. The other study assessments will insclude: 3x handgrip strength tests, 3x 6 minute walk tests (6MWT), 3x short physical performance battery tests (SPPB), 3x dual X-ray absorptiometry (DXA) body scans, and 3x nutritional assessments. Each study visit will take less than 2 hours.