RecruitingRecruiting
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
NCT05996328 · VA Office of Research and Development
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 1400 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-07-24
Estimated completion: 2030-10-31
Last updated: 2026-08-14
Interventions
Other: Home-delivered meals and short-term dietary counselingOther: Study -defined standard of care
Primary outcomes
- • Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life (within 6 weeks post-index hospital discharge)
Sponsor
VA Office of Research and Development · fed
Contacts & investigators
ContactYuan Huang · contact · Yuan.Huang1@va.gov · (203) 737-7966
ContactShirley Joyner · contact · Shirley.Joyner@va.gov · (203) 932-5711
InvestigatorScott L. Hummel, MD · study_chair, VA Ann Arbor Healthcare System, Ann Arbor, MI
All locations (16)
Birmingham VA Medical Center, Birmingham, ALRecruiting
Birmingham, Alabama, United States
VA Long Beach Healthcare System, Long Beach, CARecruiting
Long Beach, California, United States
VA Palo Alto Health Care System, Palo Alto, CARecruiting
Palo Alto, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting
West Los Angeles, California, United States
Washington DC VA Medical Center, Washington, DCRecruiting
Washington D.C., District of Columbia, United States
North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
Gainesville, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur, GARecruiting
Decatur, Georgia, United States
VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
Ann Arbor, Michigan, United States
Minneapolis VA Health Care System, Minneapolis, MNRecruiting
Minneapolis, Minnesota, United States
VA NY Harbor Healthcare System, New York, NYRecruiting
New York, New York, United States
VA Portland Health Care System, Portland, ORRecruiting
Portland, Oregon, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXRecruiting
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
Houston, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting
Salt Lake City, Utah, United States
Richmond VA Medical Center, Richmond, VARecruiting
Richmond, Virginia, United States
William S. Middleton Memorial Veterans Hospital, Madison, WIRecruiting
Madison, Wisconsin, United States