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
- Diseases
- Heart failure
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Birmingham VA Medical Center, Birmingham, AL Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Louis Stokes VA Medical Center, Cleveland, OH Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Atlanta VA Medical and Rehab Center, Decatur, GA Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| North Florida/South Georgia Veterans Health System, Gainesville, FL Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Edward Hines Jr. VA Hospital, Hines, IL Coordinator of this site? Confirm its status | Hines | United States | Recruiting |
| Michael E. DeBakey VA Medical Center, Houston, TX Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Central Arkansas Veterans Healthcare System, Little Rock, AR Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| VA Long Beach Healthcare System, Long Beach, CA Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Robley Rex VA Medical Center, Louisville, KY Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| William S. Middleton Memorial Veterans Hospital, Madison, WI Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Minneapolis VA Health Care System, Minneapolis, MN Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| VA NY Harbor Healthcare System, New York, NY Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| VA Palo Alto Health Care System, Palo Alto, CA Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| VA Portland Health Care System, Portland, OR Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Richmond VA Medical Center, Richmond, VA Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VA Salt Lake City Health Care System, Salt Lake City, UT Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Washington DC VA Medical Center, Washington, DC Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA Coordinator of this site? Confirm its status | West Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.