The Re-Prosper HF Study
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).
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 9 June 2021
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 3 November 2025
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Providence, Rhode Island, United States
📍 Richmond, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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.

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2020
  • First Submitted that Met QC Criteria 9 September 2020
  • First Posted 16 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 22 May 2024
  • Last Verified May 2024