High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Columbia University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Control; Dietary Supplement: Calorie protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05219708

AAAT7938

Details and patient eligibility

About

In this study, the investigators will determine the impact of a high calorie and high protein nutrition supplementation strategy on quality of life in participants with advanced heart failure. The investigators hypothesize that participants with advanced heart failure who receive the high calorie high protein nutrition supplementation strategy will experience an improvement in quality of life compared to those patients that receive usual care.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Calorie and protein nutritional supplementation

Experimental group

Description:

Study participants randomized to the intervention will receive 30 days worth of the nutritional supplement (i.e. Ensure Original) to be consumed twice per day in between meals in addition to standard of care for heart failure.

Treatment:

Dietary Supplement: Calorie protein supplement

Control

Active Comparator group

Description:

The control group will receive standard of care for heart failure.

Treatment:

Other: Control