Treatment of Veterans With Heart Failure With Reduced Ejection Fraction With Probenecid

Who is this study for? Patients with heart failure with reduced left ventricular ejection fraction
What treatments are being studied? Probenecid
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Heart failure with reduced ejection fraction (HFrEF) is a common cause for admission within the Veterans Affairs (VA) Health Care System. It is associated with severe impairment of physical and mental health status and carries a high risk of mortality. Even though significant progress has been made in understanding the disease process, currently, its management and treatment is limited. The investigators have discovered that a commonly used drug for the treatment of gout can be repurposed for the treatment of HFrEF. The objective of this study is the treatment of outpatient Veterans with HFrEF with probenecid to improve heart and health function. Specifically, the investigators are testing whether oral probenecid administered orally twice per day for 180 days improves heart function as measured via ultrasound of the heart (aim 1); improves exercise capacity (aim 2); and improves self-report heart failure specific health status as measured via questionnaires (aim 3).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have documented heart failure as a treated inpatient or outpatient diagnosis in the medical record.

• Left ventricular ejection 40% within the past 12 months either by echocardiogram, cardiac MRI, cardiac CT, nuclear imaging or cardiac catheterization.

⁃ NYHA class II-III

• On stable GDMT for at least 2 weeks (including at least an EBM dose of betablocker and RAAS inhibition) consistent with the EPHESUS trial criteria \[16\] or having a documented allergy or adverse reaction to betablocker and/or RAAS inhibition.

• Age 18 years or older.

Locations
United States
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
COMPLETED
Boston
Ohio
Cincinnati VA Medical Center, Cincinnati, OH
RECRUITING
Cincinnati
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Rhode Island
Providence VA Medical Center, Providence, RI
RECRUITING
Providence
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Contact Information
Primary
Jack Rubinstein, MD
jack.rubinstein@va.gov
(513) 861-3100
Time Frame
Start Date: 2021-06-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Probenecid
1 gr. orally of probenecid twice daily for 180 days
Placebo_comparator: Placebo
identical placebo (to probenecid tablets) for 180 days
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov