The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Primary Purpose
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
About this trial
This is an interventional treatment trial for Tetralogy of Fallot
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Eplerenone after drug free period
Eplerenone before drug free period
Arm Description
Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Outcomes
Primary Outcome Measures
Procollagen N-terminal Peptide 1
Procollagen III N-Terminal Peptide
Galectin 3
Secondary Outcome Measures
6 Minute Walk
Quality of Life
Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function
Full Information
NCT ID
NCT01971593
First Posted
October 23, 2013
Last Updated
April 3, 2018
Sponsor
Washington University School of Medicine
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01971593
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot, Transposition of the Great Vessels With an Arterial Switch, Single Ventricle With a Fontan Palliation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eplerenone after drug free period
Arm Type
Other
Arm Description
Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period
Arm Title
Eplerenone before drug free period
Arm Type
Other
Arm Description
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra
Primary Outcome Measure Information:
Title
Procollagen N-terminal Peptide 1
Time Frame
Baseline, 6 months and 12 months from eplerenone administration
Title
Procollagen III N-Terminal Peptide
Time Frame
Baseline, 6 months and 12 months from eplerenone administration
Title
Galectin 3
Time Frame
Baseline, 6 months and 12 months from eplerenone administration
Secondary Outcome Measure Information:
Title
6 Minute Walk
Time Frame
Baseline, 6 months, 12 months from eplerenone administration
Title
Quality of Life
Description
Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function
Time Frame
Baseline, 6 months, 12 months from eplerenone administration
Other Pre-specified Outcome Measures:
Title
Serum Creatinine
Time Frame
Baseline, 6 months, 12 months from eplerenone administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
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