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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT05996328

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Home-delivered meals and short-term dietary counseling (Other)
    Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three 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

Eligibility criteria

Inclusion Criteria: * Veterans enrolled in a VHA facility * Hospitalized (24 hours) with new heart failure (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 kilograms per meter squared (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

Conditions

Heart Failure

Locations

  • Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States
  • Central Arkansas Veterans Healthcare System, Little Rock, AR — Little Rock, Arkansas, United States
  • VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
  • VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
  • Washington DC VA Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
  • North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
  • Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
  • Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
  • Robley Rex VA Medical Center, Louisville, KY — Louisville, Kentucky, United States
  • VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
  • Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
  • VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
  • VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
  • Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States
  • William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record