The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation
Intervention: Eplerenone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Washington University School of Medicine
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.
Clinical Details
Official title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in serum markers of fibrosis.
Secondary outcome: 6 minute walkQuality of Life
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Washington University School of Medicine, Saint Louis, Missouri 63110, United States; Recruiting Ari M Cedars, MD, Phone: 314-362-1291, Email: acedars@dom.wustl.edu Philip A Ludbrook, MD, Phone: (314)362-1291, Email: pludbroo@dom.wustl.edu Ari M Cedars, MD, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: December 8, 2014
|