NCT05219708Completed
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
Source: ClinicalTrials.gov · Last updated 6 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 21 Jan 2022
- Start date
- 5 Apr 2022
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT05219708
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 5 Apr 2022 to the primary completion date, 2 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of dysphagia
- Allergy to nutritional supplement
- Listed for heart transplant
- Insulin dependent diabetes and/or most recent A1c \>7%
- Severe renal insufficiency (estimated glomerular filtration rate \<30 ml/min/1.73m\^2 at discharge)
- History of bariatric surgery
- History of persistent noncompliance with treatment recommendations as judged by the investigators
Lab values
- 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
Other
- Inability to eat orally
- Inability to eat independently
- Need for inotrope and/or mechanical support at hospital discharge
- Cirrhosis
- Nursing home residence
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.