RecruitingNot applicable

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

AR

CA

DC

FL

GA

IL

KY

MI

MN

NY

OH

OR

TN

TX

UT

VA

WI