Recruiting

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

Sponsor:

VA Office of Research and Development

Code:

NCT05996328

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Home-delivered meals and short-term dietary counseling

Study -defined standard of care

Study Details

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

Study ID

NCT05996328

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Oct 31, 2030

Anticipated

Primary completion date

Jun 29, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control

Study-defined standard of care

experimental: Home-delivered meals and short-term dietary counseling

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.

Interventions

Home-delivered meals and short-term dietary counseling

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 care

Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge

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 ]

Central Contacts and Locations

Central contacts

Yuan Huang

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

Shirley Joyner

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

Locations

Birmingham VA Medical Center, Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233-1927

Contacts

Fadi Hage, MD

(20-2)9-123)fadi.hage@va.gov

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Jennifer Ballard-Hernandez, MD

(71-4)9-9808 jennifer.ballard-Hernandez@va.gov

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Shriram Nallamshetty, MD

(65-049-000)shriram.nallamshetty@va.gov

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

Alberta Warner, MD

(31-0)4-0866 alberta.warner@va.gov

Washington DC VA Medical Center, Washington, DC

Recruiting

Washington D.C., District of Columbia, United States, 20422-0001

Contacts

Pamela Steele, MD

(20-296-850)pamela.steele@va.gov

North Florida/South Georgia Veterans Health System, Gainesville, FL

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Carsten Schmalfuss, MD

(35-2)5-6234 carsten.schmalfuss@va.gov

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Priya Kohli, MD

(40-432-111)priya.kohli@va.gov

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Scott L Hummel, MD

Scott.Hummel@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Bradley Bart, MD

(61-2)4-6387 bradley.bart@va.gov

VA NY Harbor Healthcare System, New York, NY

Recruiting

New York, New York, United States, 10010-5011

Contacts

Sundar Natarajan, MD

(21-2)6-7500 sundar.natarajan@va.gov

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Carrie Puckett, DO

(50-3) -8262 carrie.puckett@va.gov

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Recruiting

Dallas, Texas, United States, 75216-7167

Contacts

Daniel Cheeran, MD

(21-4) -1472 Daniel.Cheeran@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Savitri Fedson, MD

(71-3)7-7300 savitri.fedson@va.gov

VA Salt Lake City Health Care System, Salt Lake City, UT

Recruiting

Salt Lake City, Utah, United States, 84148-0001

Contacts

Erik Bieging, MD

(60-865-780)erik.bieging@va.gov

Richmond VA Medical Center, Richmond, VA

Recruiting

Richmond, Virginia, United States, 23249-0001

Contacts

Michael Godschalk, MD

(80-467-429)michael.godschalk@va.gov

William S. Middleton Memorial Veterans Hospital, Madison, WI

Recruiting

Madison, Wisconsin, United States, 53705-2254

Contacts

David Murray, MD

(60-8)2-0080 david.murray@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-14.