Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

1400

Study ID:

NCT05996328

Recruitment Status:

Not yet recruiting

Sponsor:

VA Office of Research and Development

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There are 2 Locations for this study

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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven Connecticut, 06516, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor Michigan, 48105, United States More Info
Scott L Hummel, MD
Contact
[email protected]
Scott L. Hummel, MD
Study Chair

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1400

Study ID:

NCT05996328

Recruitment Status:

Not yet recruiting

Sponsor:


VA Office of Research and Development

How clear is this clinincal trial information?

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