The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Stopped early · Phase 4
Conditions studied: Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
In brief
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.
Key facts
- Study ID
- NCT01971593
- Run by
- Washington University School of Medicine
- People needed
- 26
- Starts
- 2013-08-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2018-05-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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