NCT05996328 CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
| NCT ID | NCT05996328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2026-07-24 |
| Primary Completion | 2029-06-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,400 participants in total. It began in 2026-07-24 with a primary completion date of 2029-06-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Scott L. Hummel, MD
STUDY CHAIR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently Asked Questions
Who can join the NCT05996328 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05996328 currently recruiting?
Yes, NCT05996328 is actively recruiting participants. Contact the research team at Yuan.Huang1@va.gov for enrollment information.
Where is the NCT05996328 trial being conducted?
This trial is being conducted at Birmingham, United States, Long Beach, United States, Palo Alto, United States, West Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05996328 clinical trial?
NCT05996328 is sponsored by VA Office of Research and Development. The principal investigator is Scott L. Hummel, MD at VA Ann Arbor Healthcare System, Ann Arbor, MI. The trial plans to enroll 1,400 participants.
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