The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

NCT01971593

Last updated date
Study Location
Washington University School of Medicine
Saint Louis, Missouri, 63110, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation

- Patient followed regularly at Washington University-affiliated institution

- If female, willing to use 2 forms of contraception including one barrier method during protocol

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- GFR <30 ml/min


- Potassium >5.0 mmol/L


- Unable or unwilling to comply with study protocol


- Use of potassium sparing diuretics


- Use of an aldosterone blocker currently or previously


- Known intolerance of eplerenone or aldosterone blockade


- Pregnant, breastfeeding, or actively trying to get pregnant

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Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan PalliationThe Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
NCT01971593
  1. Saint Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Official Title  ICMJE Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Brief Summary

Hypothesis:

By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.

Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tetralogy of Fallot
  • Transposition of the Great Vessels With an Arterial Switch
  • Single Ventricle With a Fontan Palliation
Intervention  ICMJE Drug: Eplerenone
Other Name: Inspra
Study Arms  ICMJE
  • Eplerenone after drug free period
    Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
    Intervention: Drug: Eplerenone
  • Eplerenone before drug free period
    Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
    Intervention: Drug: Eplerenone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
26
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2013)
70
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
  • Patient followed regularly at Washington University-affiliated institution
  • If female, willing to use 2 forms of contraception including one barrier method during protocol

Exclusion Criteria:

  • GFR <30 ml/min
  • Potassium >5.0 mmol/L
  • Unable or unwilling to comply with study protocol
  • Use of potassium sparing diuretics
  • Use of an aldosterone blocker currently or previously
  • Known intolerance of eplerenone or aldosterone blockade
  • Pregnant, breastfeeding, or actively trying to get pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01971593
Other Study ID Numbers  ICMJE WI170964
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ari Cedars, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP