Heart FailureGOURMET-VANCT05996328
CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
A study testing Home-delivered meals and short-term dietary counseling in people with Heart Failure, run by VA Office of Research and Development at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home-delivered meals and short-term dietary counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 21 sitesUnited States
- Study dates
- 24 Jul 2026to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Scott L Hummel, MD, Scott.Hummel@va.gov
Scott L. Hummel, MD
- Recruiting
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
Fadi Hage, MD, (20-2)9-123), fadi.hage@va.gov
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Jonathan Goldberg, MD, 216- 79-3800 ext. 64896, jonathan.goldberg@va.gov
- Recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Daniel Cheeran, MD, (21-4) -1472, Daniel.Cheeran@va.gov
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Priya Kohli, MD, (40-432-111) ext. 202304, priya.kohli@va.gov
- Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
Carsten Schmalfuss, MD, (35-2)5-6234, carsten.schmalfuss@va.gov
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Robert Lichtenberg, MD, 708- 20-8387 ext. 21522, robert.lichtenberg@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Savitri Fedson, MD, (71-3)7-7300, savitri.fedson@va.gov
- Recruiting
Central Arkansas Veterans Healthcare System, Little Rock, AR
Little Rock, Arkansas, 72205
Barry Uretsky, MD, 409- 77-7994, barry.uretsky@va.gov
- Recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Jennifer Ballard-Hernandez, MD, (71-4)9-9808, jennifer.ballard-Hernandez@va.gov
- Recruiting
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, 40206-1433
Gerald Dryden, MD, 520- 28-6143, gerald.dryden@va.gov
- Recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
David Murray, MD, (60-8)2-0080, david.murray@va.gov
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Bradley Bart, MD, (61-2)4-6387, bradley.bart@va.gov
- Recruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Henry Ooi, MD, 615- 87-6025, Henry.ooi@va.gov
- Recruiting
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Sundar Natarajan, MD, (21-2)6-7500 ext. 3116, sundar.natarajan@va.gov
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Shriram Nallamshetty, MD, (65-049-000), shriram.nallamshetty@va.gov
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Carrie Puckett, DO, (50-3) -8262 ext. 51181, carrie.puckett@va.gov
- Recruiting
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
Michael Godschalk, MD, (80-467-429), michael.godschalk@va.gov
- Recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Erik Bieging, MD, (60-865-780), erik.bieging@va.gov
- Recruiting
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
Pamela Steele, MD, (20-296-850), pamela.steele@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Alberta Warner, MD, (31-0)4-0866, alberta.warner@va.gov
About this study
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
- Being tested
- Home-delivered meals and short-term dietary counseling, Study -defined standard of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-delivered meals and short-term dietary counselingOther
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 careOther
Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Study-defined standard of care Receives: 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 three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care. Receives: Other: Home-delivered meals and short-term dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 weeks post-index hospital discharge
Secondary outcomes (1)
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.
Measured: 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start24 Jul 2026
- Primary completion29 Jun 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm study: active intervention vs study-defined standard of care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott L. Hummel, MD, Study chair, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996328
- Sponsor's protocol ID
- 2025
- Acronym
- GOURMET-VA
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
- ClinicalTrials.gov ID
- NCT05996328
- Acronym / sponsor ID
- GOURMET-VA / 2025
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 29 Jun 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm study: active intervention vs study-defined standard of care
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Study -defined standard of careStudy-defined standard of care |
| Home-delivered meals and short-term dietary counseling | Experimental | Other: Home-delivered meals and short-term dietary counselingHome-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-delivered meals and short-term dietary counselingHome-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. | Other | Home-delivered meals and short-term dietary counseling |
| Study -defined standard of careStudy-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge | Other | Control |
Primary outcome
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.
1 secondary outcome
DAOH at 6 months post-discharge
Time frame: 6 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott L. Hummel, MD study chair
VA Ann Arbor Healthcare System, Ann Arbor, MI
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-delivered meals and short-term dietary counseling in people with Heart Failure, run by VA Office of Research and Development at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Huang ((203) 737-7966, Yuan.Huang1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.