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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Study -defined standard of care; Other: Home-delivered meals and short-term dietary counseling

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Huang; Phone Number: (203) 737-7966; Email: Yuan.Huang1@va.gov
• Study Contact Backup: Name: Shirley Joyner; Phone Number: (203) 932-5711; Email: Shirley.Joyner@va.gov

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
      • Contact: Scott L Hummel, MD; Email: Scott.Hummel@va.gov
      • Study Chair: Scott L. Hummel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Study-defined standard of care	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
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	within 6 weeks post-index hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DAOH at 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.	6 months post-discharge

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Study Chair: Scott L. Hummel, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2025 (Other Grant/Funding Number: Fondation de l'Hôtel-Dieu de Lévis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No