Heart Failure Clinical Trial

High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

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.

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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.

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Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

48

Study ID:

NCT05219708

Recruitment Status:

Recruiting

Sponsor:

Columbia University

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There is 1 Location for this study

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Columbia University Irving Medical Center
New York New York, 10032, United States More Info
Mathew S. Maurer, MD
Contact
212-932-4537
[email protected]
Elissa A. Driggin, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

48

Study ID:

NCT05219708

Recruitment Status:

Recruiting

Sponsor:


Columbia University

How clear is this clinincal trial information?

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