Repurposing Probenecid as a Positive Inotrope for the Treatment of Heart Failure (ReProsperHF)
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|ClinicalTrials.gov Identifier: NCT01814319|
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : August 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Systolic Heart Failure||Drug: Probenecid 1 gr oral twice daily Drug: Placebo||Phase 2|
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 cohorts.
Cohort 1 will enroll up to 50 subjects in a double-blinded, randomized, placebo-control, cross-over study with each patient serving as his or her own control. The subjects will have stable HF, an ejection fraction of less than or equal to 40% and NYHA II to IV symptoms. Each subject will undergo 1 week of investigational product (IP), consisting of oral probenecid therapy 1 gram twice a day or placebo with weekly follow.
The subjects will undergo EKGs, laboratory analysis, physical exams; dyspnea and quality of life questionnaires and a 6 minute walk test (MWT) at baseline. There will be 2 optional sub-studies one for echocardiographic data and the other biomarkers.
Cohort 2 will enroll up to 50 subjects in a double-blinded, randomized, placebo-control study and will include patients admitted to the hospital with acute decompensated HF. Each subject will also receive Investigational product consisting of either 1 gram orally twice daily of probenecid or placebo during their hospitalization. They will have daily follow-up with EKG and appropriate laboratory work. In addition to the EKG, laboratory analysis, physical exams, dyspnea and quality of life questionnaires and 6 MWT data will be collected; additional data such as length of hospital stay, biomarkers, use of inotropic therapy and diuretics, and rate of diuresis will also be collected.
Cohort 3 will enroll up to 50 healthy subjects in a double-blinded, randomized, placebo-control study. Each subject will also receive Investigational product consisting of either 2 grams orally of probenecid or placebo. During a 6 hour course subjects will have laboratory analysis, physical exam, telemetry, EKG and echocardiographic studies performed as measures of both safety and effect of the compound.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Initial Study on the Use of Probenecid as a Positive Inotrope for the Treatment of Systolic Heart Failure in Stable NYHA Class II to IV Patients|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Probenecid 1 gr oral twice daily or placebo will be given to the subject for 1 week (randomly assigned). A subsequent 1 week washout period will occur followed by the alternate therapy.
Drug: Probenecid 1 gr oral twice daily
Probenecid 1 gram oral twice daily
Placebo Comparator: placebo
Probenecid 1 gr oral twice daily or placebo will be given to the subject for 1 week (randomly assigned). A subsequent 1 week washout period will occur followed by the alternate (placebo) therapy.
Matching placebo oral twice daily
- 6 minute walk test [ Time Frame: 1 week ]Measure for changes in the distance that the patient can walk over 6 minutes.
- shortness of breath [ Time Frame: 1 week ]Measure objectively if there are changes in perceived shortness of breath using a standardized scale
- Ejection fraction [ Time Frame: 1 week ]We will measure via echocardiography the systolic function of the heart
- beta naturietic peptide [ Time Frame: 1 week ]We will measure for changes in the beta natuiretic peptide as a marker of cardiac function and dilatation.
- serum electrolytes [ Time Frame: 1 week ]We will measure several important electrolytes such as Na, K and Ca.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814319
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|