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

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Heart Failure

Treatments: Other: Study -defined standard of care; Other: Home-delivered meals and short-term dietary counseling

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05996328

2025

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 2 patient groups

Control

Active Comparator group

Description:

Study-defined standard of care

Treatment:

Other: Study -defined standard of care

Home-delivered meals and short-term dietary counseling

Experimental group

Description:

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.

Treatment:

Other: Home-delivered meals and short-term dietary counseling