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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-15

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm study: active intervention vs study-defined standard of care

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded

Study Groups

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Home-delivered meals and short-term dietary counseling

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.

Group Type EXPERIMENTAL

Home-delivered meals and short-term dietary counseling

Intervention Type OTHER

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.

Control

Study-defined standard of care

Group Type ACTIVE_COMPARATOR

Study -defined standard of care

Intervention Type OTHER

study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge

Interventions

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Home-delivered meals and short-term dietary counseling

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.

Intervention Type OTHER

Study -defined standard of care

study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No