The Re-Prosper HF Study

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT04551222

Run by

VA Office of Research and Development

People needed

99

Starts

2021-06-09

Expected to finish

2025-12-31

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Acute coronary syndrome or cardiac revascularization within the past 3 months.
• End stage renal disease with renal replacement therapy or creatinine clearance less than 30 ml/min [17].
• Cardiac resynchronization therapy within the past 3 months.
• Constrictive pericarditis or restrictive cardiomyopathy on cardiac imaging study (echocardiogram cardiac MRI, cardiac CT) within the last 12 months.
• Ablation for cardiac arrhythmias within the past month.
• Peripartum cardiomyopathy diagnosed within past 6 months. If LVEF is still 40% after 6 months of diagnosis, they can be enrolled into the study.
• Uncorrected cyanotic congenital heart disease.
• Severe right sided valvular disease and/or greater than moderate degree of stenotic or regurgitant left valvular disease.
• Terminal illness with expected survival of less than 12 months.
• Women who are pregnant, breast feeding, or plan to become pregnant during the study. All women in childbearing age will undergo baseline and quarterly urine pregnancy tests to ensure absence of pregnancy since the cardiometabolic assessments will be different during pregnancy.
• Oral therapy with probenecid for any indication during the preceding 3 months.
• Hypersensitivity to probenecid based on prior exposure.
• Inability to provide informed consent or study procedures due to dementia, unstable psychiatric disease, or other cause (e.g. inability to do perform exercise testing).
• Acute gout attack within the previous 3 months.
• History of uric acid kidney stones within the last year. Patient will be removed from the study if they develop urate kidney stones.
• History of blood diseases in the past year: Aplastic anemia, Hemolytic anemia, Leukopenia, Neutropenia, Pancytopenia, Thrombocytopenia or leukemia.
• Creatinine clearance (eGFR) <30 ml/min.

Where it is running

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States
• Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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