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

Tetralogy of Fallot Clinical Trial

Official title:

Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01971593
• Other study ID #: WI170964
• Status: Terminated
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: June 2016

Study information

• Verified date: April 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Single Ventricle With a Fontan Palliation
• Tetralogy of Fallot
• Transposition of Great Vessels
• Transposition of the Great Vessels With an Arterial Switch

Intervention

Drug:
• Eplerenone

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Creatinine		Baseline, 6 months, 12 months from eplerenone administration
Primary	Procollagen N-terminal Peptide 1		Baseline, 6 months and 12 months from eplerenone administration
Primary	Procollagen III N-Terminal Peptide		Baseline, 6 months and 12 months from eplerenone administration
Primary	Galectin 3		Baseline, 6 months and 12 months from eplerenone administration
Secondary	6 Minute Walk		Baseline, 6 months, 12 months from eplerenone administration
Secondary	Quality of Life	Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function	Baseline, 6 months, 12 months from eplerenone administration