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NCT05996328Recruiting

CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1400 (estimated)
First submitted
9 Aug 2023
Start date
24 Jul 2026
Primary completion date
29 Jun 2029
Lead sponsor
VA Office of Research and Development
NCT number
NCT05996328

What you commit to

  • Study type: Interventional
  • Planned participants: 1400
  • From 24 Jul 2026 to the primary completion date, 29 Jun 2029
  • 21 sites 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

  • Food allergies or intolerances that cannot be accommodated by study diet
  • Heart transplant or active transplant listing
  • Malignancy or other non-cardiac condition limiting life expectancy to \<12 months
  • Severe cognitive impairment (SLUMS score \<20, or \<19 if less than high school education completed)
  • Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study

Lab values

  • Serum potassium (non-hemolyzed) \>6.0 mmol/L during index hospitalization

Other

  • On dialysis or estimated glomerular filtration rate \<30 at randomization
  • Left ventricular assist device present or anticipated \<6 months
  • Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet
  • Lack of space to store food for a week or equipment to prepare food
  • Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)
  • Body mass index \>50 kilograms per meter squared (kg/m2)

Who the study is looking for

  • Veterans enrolled in a VHA facility
  • Hospitalized (24 hours) with new heart failure (HF) or worsening chronic HF
  • Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed)
  • Able and willing to provide informed consent and perform study activities

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA Ann Arbor Healthcare System, Ann Arbor, MI
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
Birmingham VA Medical Center, Birmingham, AL
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Louis Stokes VA Medical Center, Cleveland, OH
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Coordinator of this site? Confirm its status
DecaturUnited StatesRecruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
Edward Hines Jr. VA Hospital, Hines, IL
Coordinator of this site? Confirm its status
HinesUnited StatesRecruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Central Arkansas Veterans Healthcare System, Little Rock, AR
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
VA Long Beach Healthcare System, Long Beach, CA
Coordinator of this site? Confirm its status
Long BeachUnited StatesRecruiting
Robley Rex VA Medical Center, Louisville, KY
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
Minneapolis VA Health Care System, Minneapolis, MN
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
VA NY Harbor Healthcare System, New York, NY
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
VA Palo Alto Health Care System, Palo Alto, CA
Coordinator of this site? Confirm its status
Palo AltoUnited StatesRecruiting
VA Portland Health Care System, Portland, OR
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Richmond VA Medical Center, Richmond, VA
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Washington DC VA Medical Center, Washington, DC
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Coordinator of this site? Confirm its status
West Los AngelesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.