Clinical trial NCT01971593: The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Official title: Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tetralogy of Fallot
Transposition of the Great Vessels With an Arterial Switch
Single Ventricle With a Fontan Palliation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-10-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Procollagen N-terminal Peptide 1
timeFrame: Baseline, 6 months and 12 months from eplerenone administration
measure: Procollagen III N-Terminal Peptide
timeFrame: Baseline, 6 months and 12 months from eplerenone administration
measure: Galectin 3
timeFrame: Baseline, 6 months and 12 months from eplerenone administration
Secondary outcomes:
measure: 6 Minute Walk
timeFrame: Baseline, 6 months, 12 months from eplerenone administration
measure: Quality of Life
timeFrame: Baseline, 6 months, 12 months from eplerenone administration
Other outcomes:
measure: Serum Creatinine
timeFrame: Baseline, 6 months, 12 months from eplerenone administration
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: