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

NCT05996328 | Not Yet Recruiting

• 1 other identifier: 2025
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

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

  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: 1. 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. 2. 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 Outcomes (1)

• DAOH at 6 months post-discharge

  6 months post-discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

Study-defined standard of care

Other: Study -defined standard of care

Home-delivered meals and short-term dietary counseling

EXPERIMENTAL

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

Interventions

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.

Home-delivered meals and short-term dietary counseling

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

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott L. Hummel, MD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  STUDY CHAIR

Central Study Contacts

Yuan Huang

CONTACT

(203) 737-7966; Yuan.Huang1@va.gov

Shirley Joyner

CONTACT

(203) 932-5711; Shirley.Joyner@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): October 31, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)