Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01971593
Other study ID # WI170964
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02534792 - Early Revalvulation After Fallot Repair Improves Clinical Outcome N/A
Completed NCT00536432 - Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot N/A
Not yet recruiting NCT05485545 - Asynchrony in Operated Tetralogy of Fallot N/A
Completed NCT01941576 - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot N/A
Active, not recruiting NCT03983512 - PULSTA Transcatheter Pulmonary Valve Pre-Approval Study N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Completed NCT01762124 - Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV) N/A
Active, not recruiting NCT02161471 - Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
Not yet recruiting NCT05916976 - Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment N/A
Recruiting NCT04106479 - NIRS in Congenital Heart Defects - Correlation With Echocardiography
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05236153 - Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot N/A
Recruiting NCT03049995 - Stress Echo 2020 - The International Stress Echo Study
Completed NCT02586740 - Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation N/A
Terminated NCT00564993 - Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot Phase 3
Recruiting NCT05122962 - Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Completed NCT06097377 - Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study
Completed NCT03835494 - Analysis of RV-Dysfunction in Fallot Patients N/A
Not yet recruiting NCT03275844 - Physical Capacity and Activity in Children With Congenital Heart Disease N/A
Recruiting NCT02590679 - Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p Phase 2/Phase 3