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

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

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.

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