High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

NCT05219708 | Completed

• 1 other identifier: AAAT7938
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in handgrip strength

  Up to 30 days

• Change in Short Physical Performance Battery (SPPB) Score

  Up to 30 days

Study Arms (2)

Calorie and protein nutritional supplementation

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

The control group will receive standard of care for heart failure.

Other: Control

Interventions

Calorie protein supplement DIETARY_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

Calorie and protein nutritional supplementation

Control OTHER

Standard of care for heart failure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mathew S. Maurer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: April 5, 2022
• Primary Completion: April 2, 2024
• Study Completion: June 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)