The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

NCT ID: NCT01971593

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-06-30

Brief 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.

Conditions

Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eplerenone after drug free period

Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period

Group Type: OTHER

Eplerenone

Intervention Type: DRUG

Eplerenone before drug free period

Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period

Group Type: OTHER

Eplerenone

Intervention Type: DRUG

Interventions

Eplerenone

Intervention Type: DRUG

Other Intervention Names

Inspra

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ari Cedars

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

WI170964

Identifier Type: -

Identifier Source: org_study_id