Status:
NOT_YET_RECRUITING
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Heart Failure
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- aged 60 years
- 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
- 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
Key Trial Info
Start Date :
April 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT05996328
Start Date
April 15 2026
End Date
September 30 2026
Last Update
October 22 2025
Active Locations (1)
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1
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303