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NCT Number: NCT05996328

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location contact

Scott L Hummel, MD

CONTACT

[email protected]

Scott L. Hummel, MD

STUDY_CHAIR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-delivered meals and short-term dietary counseling

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.

Study -defined standard of care

Other

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

Primary outcomes

  1. Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life

    Time frame: within 6 weeks post-index hospital discharge

    All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown:

    • Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied.
    • Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5.

    The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.

Secondary outcomes

  1. DAOH at 6 months post-discharge

    Time frame: 6 months post-discharge

    This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley Joyner

CONTACT

[email protected]

(203) 932-5711

Yuan Huang

CONTACT

[email protected]

(203) 737-7966

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: GOURMET-VA

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 18, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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