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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01971593
Recruitment Status : Terminated (Investigator left institution)
First Posted : October 29, 2013
Last Update Posted : February 18, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Tetralogy of Fallot Transposition of the Great Vessels With an Arterial Switch Single Ventricle With a Fontan Palliation Drug: Eplerenone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Study Start Date : August 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Arms and Interventions

Arm Intervention/treatment
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 Name: Inspra
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 Name: Inspra

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 6 minute walk [ Time Frame: 6 months, 12 months ]
  2. Quality of Life [ Time Frame: 6 months, 12 months ]

Other Outcome Measures:
  1. Serum creatinine [ Time Frame: 1 month, 6 months, 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01971593

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
More Information

Responsible Party: Ari Cedars, Assistant Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01971593     History of Changes
Other Study ID Numbers: WI170964
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Transposition of Great Vessels
Heart Diseases
Heart Defects, Congenital
Tetralogy of Fallot
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents