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

April 3, 2018 updated by: Ari Cedars, Washington University School of Medicine

Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eplerenone after drug free period
Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
Drug: Eplerenone
Other Names:
  • Inspra
Other: Eplerenone before drug free period
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Drug: Eplerenone
Other Names:
  • Inspra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Procollagen N-terminal Peptide 1
Time Frame: Baseline, 6 months and 12 months from eplerenone administration
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
Baseline, 6 months and 12 months from eplerenone administration
Galectin 3
Time Frame: Baseline, 6 months and 12 months from eplerenone administration
Baseline, 6 months and 12 months from eplerenone administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk
Time Frame: Baseline, 6 months, 12 months from eplerenone administration
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
Baseline, 6 months, 12 months from eplerenone administration

Other Outcome Measures

Outcome Measure
Time Frame
Serum Creatinine
Time Frame: Baseline, 6 months, 12 months from eplerenone administration
Baseline, 6 months, 12 months from eplerenone administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI170964

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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