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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01971593
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in serum markers of fibrosis. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Procollagen N-terminal peptide 1, Procollagen N-terminal peptide 3, Galectin 3


Secondary Outcome Measures:
  • 6 minute walk [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    SF-36


Other Outcome Measures:
  • Serum creatinine [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: August 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971593

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ari M Cedars, MD    314-362-1291    acedars@dom.wustl.edu   
Contact: Philip A Ludbrook, MD    (314)362-1291    pludbroo@dom.wustl.edu   
Principal Investigator: Ari M Cedars, MD         
Sponsors and Collaborators
Washington University School of Medicine
Pfizer
  More Information

No publications provided

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
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014