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High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calorie protein supplement
Control
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calorie and protein nutritional supplementation

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
December 28, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05219708
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calorie and protein nutritional supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will receive standard of care for heart failure.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calorie protein supplement
Intervention Description
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
Other
Intervention Name(s)
Control
Intervention Description
Standard of care for heart failure
Primary Outcome Measure Information:
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Description
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.
Time Frame
Up to 30 days
Other Pre-specified Outcome Measures:
Title
Change in handgrip strength
Description
Handgrip strength as measured by Jamar Hydraulic Hand Dynamometer
Time Frame
Up to 30 days
Title
Change in Short Physical Performance Battery (SPPB) Score
Description
SPPB measures functional capacity. Scores range from 0 (lowest physical performance) to 12 (highest physical performance).
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathew S. Maurer, MD
Phone
212-932-4537
Email
msm10@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew S. Maurer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew S. Maurer, MD
Phone
212-932-4537
Email
msm10@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Elissa A. Driggin, MD
Email
ed2761@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

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