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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 walk

Quality 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

Page last updated: August 23, 2015

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