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

Recruiting now · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT05996328
Run by: VA Office of Research and Development
People needed: 1400
Starts: 2026-07-24
Expected to finish: 2030-10-31
Last updated by the study team: 2026-08-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Veterans enrolled in a VHA facility
Hospitalized ( 24 hours) with new 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

You may not qualify if…

Food allergies or intolerances that cannot be accommodated by study diet
On dialysis or estimated glomerular filtration rate <30 at randomization
Serum potassium (non-hemolyzed) >6.0 mmol/L during index hospitalization
Heart transplant or active transplant listing
Left ventricular assist device present or anticipated <6 months
Malignancy or other non-cardiac condition limiting life expectancy to <12 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 cognitive impairment (SLUMS score <20, or <19 if less than high school education completed)
Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)
Body mass index >50 kg/m2
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

Where it is running

Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States (enrolling)
VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States (enrolling)
Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States (enrolling)
North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)
Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)
VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (enrolling)
Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (enrolling)
VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (enrolling)
VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (enrolling)
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (enrolling)
VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (enrolling)
William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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