High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of a High Energy and High Protein Nutrition Supplementation Intervention on Outcomes in Patients With Advanced Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Calorie protein supplement
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie and protein nutritional supplementation<br>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. | Dietary Supplement: Calorie protein supplement<br>* Participants assigned to the intervention group will receive the calorie and protein supplement (i.e. Ensure Original) to be consumed twice daily between meals for 30 days in addition to standard of care for heart failure<br>|
| Active Comparator: Control<br>The control group will receive standard of care for heart failure. | Other: Control<br>* Standard of care for heart failure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | 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. | Up to 30 days |