Status:
COMPLETED
Repurposing Probenecid as a Positive Inotrope for the Treatment of Heart Failure
Lead Sponsor:
University of Cincinnati
Conditions:
Systolic Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Probenecid is an FDA approved drug for the treatment gout and hyperuricemia. It has been used safely in humans for decades for this and other indications. The investigators have recently discovered th...
Detailed Description
The investigators will test the hypothesis that oral administration of probenecid results in improved symptomatology and heart function in patients with systolic heart failure. There will be three coh...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 years of age or older
- EF \< 40% via echocardiogram within the past 12 months
- Stable dose of heart failure medications for \> past 1 month
- NYHA class II - IV
- Exclusion Criteria
- Pregnant or lactating female
- Receiving IV inotrope
- History of significant non-compliance
- Unwilling to adhere to the protocol
- Systemic systolic BP less than 90 mmHg at screening visit
- History of allergy to probenecid
- History of gout
- History of renal calculi
- Recent unstable coronary artery syndromes (USA, admission to hospital for AMI, revascularization procedure, or acute decompensated HF requiring hospitalization) within the past 3 months.
- Implant of CRT device within the past 3 months
- TIA, CVA or major surgery within the past 3 months
- Valvular heart disease (more than moderate stenosis or insufficiency)
- HOCM, myocarditis, constrictive pericarditis, congenital heart disease, 14 Active chemotherapy, significant malignancy or uncontrolled metabolic disease (untreated hyper or hypothyroidism, Cushing's disease etc.)What about uncontrolled DM?? HgA1C \> etc
- 15\. Elevated liver enzymes (\> 3 times ULN), 16. Current atrial fibrillation or frequent PVCs (should we define this now) 17. End stage renal disease (dialysis dependent) or worsening renal insufficiency should define now.
- 18\. History of gastric ulcerations, significant gastroesophageal reflux. 19. Other condition that in the opinion of the investigator, would make the subject a poor candidate for the study.
- 20\. Co-administration of any medication that in the opinion of the investigator places the subject at increased risks due to potential adverse drug interactions.
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01814319
Start Date
March 1 2013
End Date
June 1 2015
Last Update
August 26 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267