A SkeleTal Muscle Recovery Intervention with Dietary Protein in Heart Failure

Launched by TUFTS MEDICAL CENTER · Nov 17, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding protein to the diet can help prevent muscle loss in patients with heart failure, specifically those with a condition called heart failure with reduced ejection fraction (HFrEF). Muscle wasting and weight loss are common issues for these patients, and researchers want to see if different amounts of protein supplementation using a product called Ensure® can improve muscle mass in the arms and legs. The study will compare three groups: one with no protein, one with low protein, and one with high protein to find out if increased protein intake can help.

To be eligible for the trial, participants need to be between 18 and 100 years old, have a specific level of heart function (measured by left ventricular ejection fraction), and have experienced severe heart failure symptoms or hospitalizations in the past year. Participants will receive medical care as usual and will be monitored throughout the trial. They should be aware that certain health conditions, allergies, or a very high body weight may exclude them from joining. Overall, this study aims to better understand how dietary changes can support muscle health in heart failure patients.

Gender

ALL

Eligibility criteria

• 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 weight loss \>5% of bodyweight over the past year; vii) Moderate or severe muscle wasting on physical examination; viii) NT-proBNP ≥900 pg/mL
• Exclusion Criteria:
• • 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 left ventricular assist device (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 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