Heart Failure Clinical Trial
— Re-Prosper HFOfficial title:
Treatment of Veterans With Heart Failure With Reduced Ejection Fraction With Probenecid
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).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | November 3, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in cardiac function | The main primary outcome is echocardiogram-derived EF. The investigators will use Definity echo contrast if adequate endocardial border definition cannot be ascertained for EF calculation in apical 4 and apical 2 using volumetric tracing analysis and modified Simpson's. The echosonographers from all sites will follow the same standard study ECHO procedure to obtain the views | 6 months | |
Secondary | Change from baseline in exercise tolerance via a symptom-limited exercise test on a cycle ergometer | The investigators will perform a maximal bicycle exercise stress test (BEST) on a cycle ergometer (Ergocard II, Esaote) with 25-W workload increments at 3-minute intervals. to adapt to patients with low functional capacity as previously described and with all the standard precautions. Results will be converted to Vo2 max using standard formula and compared to baseline | 6 months | |
Secondary | Change from baseline in The Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ5D | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23 item instrument validated in stable and decompensated HF patients with HFpEF and HFrEF. The questionnaire takes 4-6 minutes to complete and reflects disease-specific health status over the prior two weeks. Overall health status (EQ5D) (Appendix) is a well-known generic measure of health status. It has 5 questions that address five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety or depression) with five levels ranging from 'no problems' to 'extreme problems' each |
6 months |
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