Clinical trial NCT05996328: CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Official title: CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-18
Enrollment: 1400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm study: active intervention vs study-defined standard of care
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* aged 60 years
* 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

Primary outcomes:
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
timeFrame: within 6 weeks post-index hospital discharge
Secondary outcomes:
measure: DAOH at 6 months post-discharge
timeFrame: 6 months post-discharge
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Scott L. Hummel, MD
role: STUDY_CHAIR
References: