High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

This is a single center, prospective randomized open with blinded endpoint (PROBE) trial with an individual follow-up time of 30 days duration designed to determine the impact of a high calorie high protein nutritional supplementation strategy on quality of life and functional outcomes in adults with malnutrition advanced systolic heart failure. 48 participants will be randomized in a stratified fashion by gender and Subjective Global Assessment (SGA) class (B versus C). Study subjects will receive a calorie and protein nutritional supplement, Ensure Original, manufactured by Abbott laboratories for 30 days after hospital discharge. The study site will be Columbia University Irving Medical Center. Investigators will be blinded to group assignment and dietary recalls until the completion of the study.

Inclusion criteria

• Patients aged ≥ 18 years
• Hospitalized at Columbia University Irving Medical Center/New York Presbyterian Hospital
• Left ventricular ejection fraction <=40%
• At least mild malnutrition as determined by the Subjective Global Assessment (SGA)

Exclusion criteria

• Inability to eat orally
• Inability to eat independently
• History of dysphagia
• Allergy to nutritional supplement
• Need for inotrope and/or mechanical support at hospital discharge
• Listed for heart transplant
• Insulin dependent diabetes and/or most recent A1c >7%
• Having two or more results of a serum potassium >5.0 mmol/L during hospitalization or history of serum potassium >6.0 mmol/L, and/or at an excessive risk of hyperkalemia as judged by the investigators
• Severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m^2 at discharge)
• Cirrhosis
• History of bariatric surgery
• Nursing home residence
• History of persistent noncompliance with treatment recommendations as judged by the investigators