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High Calorie High Protein Nutrition Supplementation in Advanced Heart Failure

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05219708
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
7.9
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Calorie protein supplement
  • Other: Control
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of a High Energy and High Protein Nutrition Supplementation Intervention on Outcomes in Patients With Advanced Heart Failure
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Dietary Supplement: 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
Active Comparator: Control

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

Other: Control
Standard of care for heart failure

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Change in handgrip strength [Up to 30 days]

    Handgrip strength as measured by Jamar Hydraulic Hand Dynamometer

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Irving Medical Center New York New York United States 10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Principal Investigator: Mathew S. Maurer, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT05219708
Other Study ID Numbers:
  • AAAT7938
First Posted:
Feb 2, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jul 20, 2022