High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Control; Dietary Supplement: Calorie protein supplement

• Registration Number: NCT05219708
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-04-05
• Primary Completion: 2024-04-02
• Study Completion: 2024-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group will receive standard of care for heart failure.
Calorie and protein nutritional supplementation	Calorie protein supplement	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.

Primary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score	Up to 30 days	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered questionnaire to assess quality of life in heart failure. Scores range from 0-100 with a higher score indicating better quality of life.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States