CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA) (GOURMET-VA)
Heart Failure
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: 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 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
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- VA Ann Arbor Healthcare System, Ann Arbor, MI
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
Home-delivered meals and short-term dietary counseling
Study-defined standard of care
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus two additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.