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

RecruitingNA

Sponsor: VA Office of Research and Development

Conditions: Heart Failure

Interventions: Home-delivered meals and short-term dietary counseling, Study -defined standard of care

Countries: United States

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (16)

Birmingham, Alabama, United States
Long Beach, California, United States
Palo Alto, California, United States
West Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Decatur, Georgia, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
New York, New York, United States
Portland, Oregon, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States