NCT05996328 · VA Office of Research and Development
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
(GOURMET-VA)
What this study is about
The purpose of this multi-center clinical trial is to study the effectiveness and safety of providing nutritional support added to the study-defined the usual treatment which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined the usual treatment alone.
View original scientific 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
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.
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
Primary outcome measures
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: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Long Beach, California
- Palo Alto, California
- West Los Angeles, California
- Washington D.C., District of Columbia
- Gainesville, Florida
- Decatur, Georgia
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- New York, New York
- Portland, Oregon
- Dallas, Texas
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations