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

The Washington University

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01971593

WI170964

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Eplerenone after drug free period

Other group

Description:

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

Treatment:

Drug: Eplerenone

Eplerenone before drug free period

Other group

Description:

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

Treatment:

Drug: Eplerenone