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Recruiting
NCT05996328
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Conditions: Heart Failure
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1400
Sponsor: VA Office of Research and Development
Location: Birmingham VA Medical Center, Birmingham, AL Birmingham Alabama
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 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 \6.0 mmol/L during index hospitalization
* Heart transplant or active transplant listing
* Left ventricular assist device present or anticipated \
Source: ClinicalTrials.gov (NCT05996328). StuddyBuddy aggregates publicly available trial information.