Status:
COMPLETED
High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure
Lead Sponsor:
Columbia University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 inv...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05219708
Start Date
April 5 2022
End Date
June 30 2024
Last Update
December 6 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032