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Trial record 10 of 112 for:    EPLERENONE

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

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ClinicalTrials.gov Identifier: NCT01971593
Recruitment Status : Terminated (Investigator left institution)
First Posted : October 29, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE October 29, 2013
Results First Submitted Date  ICMJE January 25, 2018
Results First Posted Date  ICMJE May 4, 2018
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Procollagen N-terminal Peptide 1 [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]
  • Procollagen III N-Terminal Peptide [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]
  • Galectin 3 [ Time Frame: Baseline, 6 months and 12 months from eplerenone administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
Change in serum markers of fibrosis. [ Time Frame: 6 months and 12 months ]
Procollagen N-terminal peptide 1, Procollagen N-terminal peptide 3, Galectin 3
Change History Complete list of historical versions of study NCT01971593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • 6 Minute Walk [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]
  • Quality of Life [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]
    Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
  • 6 Minute Walk [ Time Frame: 6 months, 12 months ]
  • Quality of Life [ Time Frame: 6 months, 12 months ]
    SF-36
Current Other Pre-specified Outcome Measures
 (submitted: April 3, 2018)
Serum Creatinine [ Time Frame: Baseline, 6 months, 12 months from eplerenone administration ]
Original Other Pre-specified Outcome Measures
 (submitted: October 23, 2013)
Serum Creatinine [ Time Frame: 1 month, 6 months, 12 months ]
 
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