NCT05219708

High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-05
• Primary completion: 2024-04-02
• Completion: 2024-06-30
• First posted: 2022-02-02
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States