Clinical trial NCT05219708: High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure
Official title: Impact of a High Energy and High Protein Nutrition Supplementation Intervention on Outcomes in Patients With Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
measure: Change in handgrip strength
timeFrame: Up to 30 days
measure: Change in Short Physical Performance Battery (SPPB) Score
timeFrame: Up to 30 days
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Mathew S. Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References: