High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219708
• Other study ID #: AAAT7938
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Mathew S. Maurer, MD
• Phone: 212-932-4537
• Email: msm10[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Calorie protein supplement
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

Other:
• Control
Standard of care for heart failure

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in handgrip strength	Handgrip strength as measured by Jamar Hydraulic Hand Dynamometer	Up to 30 days
Other	Change in Short Physical Performance Battery (SPPB) Score	SPPB measures functional capacity. Scores range from 0 (lowest physical performance) to 12 (highest physical performance).	Up to 30 days
Primary	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