NCT01814319

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 that this drug can also stimulate other receptors in the heart and therefore improve its function. The hypothesis of this study is that probenecid can be used to improve the function of the heart and therefore the symptoms in patients with heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

March 14, 2013

Last Update Submit

August 24, 2015

Conditions

Systolic Heart Failure

Keywords

heart failureejection fraction equal or less than 40%

Outcome Measures

Primary Outcomes (2)

  • 6 minute walk test

    Measure for changes in the distance that the patient can walk over 6 minutes.

    1 week

  • shortness of breath

    Measure objectively if there are changes in perceived shortness of breath using a standardized scale

    1 week

Secondary Outcomes (3)

  • Ejection fraction

    1 week

  • beta naturietic peptide

    1 week

  • serum electrolytes

    1 week

Study Arms (2)

Probenecid

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Probenecid 1 gr oral twice dailyDRUG

Probenecid 1 gram oral twice daily

Probenecid
PlaceboDRUG

Matching placebo oral twice daily

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \. 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.
  • \. 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

  • Robbins N, Gilbert M, Kumar M, McNamara JW, Daly P, Koch SE, Conway G, Effat M, Woo JG, Sadayappan S, Rubinstein J. Probenecid Improves Cardiac Function in Patients With Heart Failure With Reduced Ejection Fraction In Vivo and Cardiomyocyte Calcium Sensitivity In Vitro. J Am Heart Assoc. 2018 Jan 13;7(2):e007148. doi: 10.1161/JAHA.117.007148.

    PMID: 29331959DERIVED

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 19, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(1)