The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/6/2018 |
| Start Date: | August 2013 |
| End Date: | June 2016 |
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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