CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding nutrition support to usual study care is safe and helpful for Veterans hospitalized with new or worsening heart failure. Heart failure means the heart does not pump blood as well as it should. Both groups get diet education and one diet counseling visit soon after leaving the hospital.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are a Veteran enrolled at a Veterans Health Administration (VHA) facility.
- You have been hospitalized for at least 24 hours with new or worsening heart failure.
- You can safely eat regular food and drink regular liquids without needing pureed food or thickened drinks.
- You can and agree to give informed consent and take part in study activities.
Who can't join
- You have food allergies or intolerances that the study diet cannot meet.
- You are on dialysis, have a kidney filtering rate below 30 when assigned to a study group, or had a blood potassium level above 6.0 mmol/L during this hospital stay.
- You have had a heart transplant, are on an active transplant list, or have or expect to need a heart pump device within 6 months.
- You have cancer or another illness not related to your heart that limits your expected life span to less than 12 months.
- After discharge, you will go to a skilled nursing facility or another place where you cannot control your diet, or you lack space to store a week's food or equipment to prepare it.
- You have severe problems with memory or thinking based on a screening test, or severe trouble getting enough food based on a food access survey.
- Your body mass index (BMI), a measure of weight compared with height, is above 50.
- The study doctor believes another health, mental health, behavior, or practical issue would make it unlikely you could take part in or finish the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 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 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
Study sites (21)
AL
- Birmingham VA Medical Center, Birmingham, AL · Birmingham, AL 35233-1927Fadi Hage, MD · Study contact · (20-2)9-123) · fadi.hage@va.govMore trials in Birmingham
AR
- Central Arkansas Veterans Healthcare System, Little Rock, AR · Little Rock, AR 72205Barry Uretsky, MD · Study contact · 409- 77-7994 · barry.uretsky@va.govMore trials in Little Rock
CA
- VA Long Beach Healthcare System, Long Beach, CA · Long Beach, CA 90822Jennifer Ballard-Hernandez, MD · Study contact · (71-4)9-9808 · jennifer.ballard-Hernandez@va.govMore trials in Long Beach
- VA Palo Alto Health Care System, Palo Alto, CA · Palo Alto, CA 94304-1207Shriram Nallamshetty, MD · Study contact · (65-049-000) · shriram.nallamshetty@va.govMore trials in Palo Alto
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA · West Los Angeles, CA 90073-1003Alberta Warner, MD · Study contact · (31-0)4-0866 · alberta.warner@va.govMore trials in West Los Angeles
DC
- Washington DC VA Medical Center, Washington, DC · Washington D.C., DC 20422-0001Pamela Steele, MD · Study contact · (20-296-850) · pamela.steele@va.govMore trials in Washington D.C.
FL
- North Florida/South Georgia Veterans Health System, Gainesville, FL · Gainesville, FL 32608-1135Carsten Schmalfuss, MD · Study contact · (35-2)5-6234 · carsten.schmalfuss@va.govMore trials in Gainesville
GA
- Atlanta VA Medical and Rehab Center, Decatur, GA · Decatur, GA 30033-4004Priya Kohli, MD · Study contact · (40-432-111) ext. 202304 · priya.kohli@va.govMore trials in Decatur
IL
- Edward Hines Jr. VA Hospital, Hines, IL · Hines, IL 60141-3030Robert Lichtenberg, MD · Study contact · 708- 20-8387 ext. 21522 · robert.lichtenberg@va.govMore trials in Hines
KY
- Robley Rex VA Medical Center, Louisville, KY · Louisville, KY 40206-1433Gerald Dryden, MD · Study contact · 520- 28-6143 · gerald.dryden@va.govMore trials in Louisville
MI
- VA Ann Arbor Healthcare System, Ann Arbor, MI · Ann Arbor, MI 48105-2303Scott L Hummel, MD · Study contact · Scott.Hummel@va.govScott L. Hummel, MD · Study chairMore trials in Ann Arbor
MN
- Minneapolis VA Health Care System, Minneapolis, MN · Minneapolis, MN 55417-2309Bradley Bart, MD · Study contact · (61-2)4-6387 · bradley.bart@va.govMore trials in Minneapolis
NY
- VA NY Harbor Healthcare System, New York, NY · New York, NY 10010-5011Sundar Natarajan, MD · Study contact · (21-2)6-7500 ext. 3116 · sundar.natarajan@va.govMore trials in New York
OH
- Louis Stokes VA Medical Center, Cleveland, OH · Cleveland, OH 44106-1702Jonathan Goldberg, MD · Study contact · 216- 79-3800 ext. 64896 · jonathan.goldberg@va.govMore trials in Cleveland
OR
- VA Portland Health Care System, Portland, OR · Portland, OR 97207-2964Carrie Puckett, DO · Study contact · (50-3) -8262 ext. 51181 · carrie.puckett@va.govMore trials in Portland
TN
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN · Nashville, TN 37212-2637Henry Ooi, MD · Study contact · 615- 87-6025 · Henry.ooi@va.govMore trials in Nashville
TX
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX · Dallas, TX 75216-7167Daniel Cheeran, MD · Study contact · (21-4) -1472 · Daniel.Cheeran@va.govMore trials in Dallas
- Michael E. DeBakey VA Medical Center, Houston, TX · Houston, TX 77030-4211Savitri Fedson, MD · Study contact · (71-3)7-7300 · savitri.fedson@va.govMore trials in Houston
UT
- VA Salt Lake City Health Care System, Salt Lake City, UT · Salt Lake City, UT 84148-0001Erik Bieging, MD · Study contact · (60-865-780) · erik.bieging@va.govMore trials in Salt Lake City
VA
- Richmond VA Medical Center, Richmond, VA · Richmond, VA 23249-0001Michael Godschalk, MD · Study contact · (80-467-429) · michael.godschalk@va.govMore trials in Richmond
WI
- William S. Middleton Memorial Veterans Hospital, Madison, WI · Madison, WI 53705-2254David Murray, MD · Study contact · (60-8)2-0080 · david.murray@va.govMore trials in Madison