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NCT01971593 · ClinicalTrials.gov registry record · Phase 4
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
A Phase 4 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01971593 is a Phase 4 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 26 participants.
The verdict
NCT01971593, a Phase 4 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG Eplerenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01971593
The ClinicalTrials.gov registry entry for NCT01971593 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eplerenone is the first listed.
NCT01971593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01971593 about?
NCT01971593 is a clinical study titled "The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult 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...
What is the current status of trial NCT01971593?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2013-08. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01971593?
The interventions under investigation include: Eplerenone (DRUG).
Who is sponsoring clinical trial NCT01971593?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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