Clinical trial for Heart Failure
Official title CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
ClinicalTrials.gov ID: NCT05996328
What this study is testing
- What it's testing
- The study wants to see if giving extra nutritional support, along with standard care, is safe and effective for heart‑failure patients.
- Who it's for
- Veterans who have been discharged from the hospital with heart failure.
- What's involved
- Participants receive a nutrition plan and support in addition to the usual diet education and one counseling session, or they receive only the usual care.
- Time commitment
- The study lasts for the period of the follow‑up visits after discharge, with several scheduled check‑ins to monitor progress.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- Able and willing to provide informed consent and perform study activities
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Long Beach, California, United States
- Palo Alto, California, United States
- West Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Decatur, Georgia, United States
- Hines, Illinois, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Long Beach, California, United States; Palo Alto, California, United States; West Los Angeles, California, United States; Washington D.C., District of Columbia, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.