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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01971593
• Date of registration: 23/10/2013
• Prospective Registration: No
• Primary sponsor: Washington University School of Medicine
• Public title: The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
• Scientific title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
• Date of first enrolment: August 2013
• Target sample size: 26
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01971593
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tetralogy of Fallot

Single Ventricle With a Fontan Palliation

Transposition of the Great Vessels With an Arterial Switch

Intervention(s)

Drug: Eplerenone

Primary Outcome(s)

Galectin 3 [Time Frame: Baseline, 6 months and 12 months from eplerenone administration]

Procollagen III N-Terminal Peptide [Time Frame: Baseline, 6 months and 12 months from eplerenone administration]

Procollagen N-terminal Peptide 1 [Time Frame: Baseline, 6 months and 12 months from eplerenone administration]

Secondary Outcome(s)

Quality of Life [Time Frame: Baseline, 6 months, 12 months from eplerenone administration]

6 Minute Walk [Time Frame: Baseline, 6 months, 12 months from eplerenone administration]

Secondary ID(s)

WI170964

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Results

• Results available: Yes
• Date Posted: 04/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01971593