Heart Failure
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTCalorie 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
OTHERControl
Standard of care for heart failure
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Up to 30 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in handgrip strength | Up to 30 days | Handgrip strength as measured by Jamar Hydraulic Hand Dynamometer |
| Change in Short Physical Performance Battery (SPPB) Score | Up to 30 days | SPPB measures functional capacity. Scores range from 0 (lowest physical performance) to 12 (highest physical performance). |
Countries
United States
Outcome results
None listed