MedDataX Logo

High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

NCT ID: NCT05219708

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Calorie and protein nutritional supplementation

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.

Group Type EXPERIMENTAL

Calorie protein supplement

Intervention Type 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

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Standard of care for heart failure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calorie 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

Intervention Type DIETARY_SUPPLEMENT

Control

Standard of care for heart failure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mathew S. Maurer, MD

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mathew S. Maurer, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAAT7938

Identifier Type: -

Identifier Source: org_study_id