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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: Calorie protein supplement; Other: Control

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathew S. Maurer, MD; Phone Number: 212-932-4537; Email: msm10@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Mathew S. Maurer, MD; Phone Number: 212-932-4537; Email: msm10@cumc.columbia.edu
      • Contact: Elissa A. Driggin, MD; Email: ed2761@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calorie and protein nutritional supplementation; 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; 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
Active Comparator: Control; The control group will receive standard of care for heart failure.	Other: Control; Standard of care for heart failure

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in handgrip strength	Handgrip strength as measured by Jamar Hydraulic Hand Dynamometer	Up to 30 days
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Mathew S. Maurer, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AAAT7938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No