Status:
UNKNOWN
Sildenafil for Liver Fibrosis in Adolescents and Adults After Fontan Operation
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Liver Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
Fontan operation is currently the most common procedure performed in patients with single-ventricle physiology. This surgery allows for passive caval blood flow to the pulmonary arteries in the absenc...
Detailed Description
Research Design and Methods Patients and Methods 1. Study cohort: The adolescent and adult patients (age ≥ 12 years) with anatomic and/or functional univentricular heart receive Fontan procedure ...
Eligibility Criteria
Inclusion
- Patients age ≥ 12 years with anatomic and/or functional univentricular heart receive Fontan procedure followed at our institute (including the patients with heart failure or pregnancy).
- Patients without taking organic nitrates and not allergic to Sildenafil.
Exclusion
- The patients cannot safely receive MRI examination, including patients with severe renal dysfunction, or after pacemaker or implantable cardioverter defibrillator implantation.
- Patients having known liver disease (such as viral hepatitis, alcoholic liver disease, etc.) other than FALD.
- Patients are under sildenafil or any pulmonary vasodilator therapy for lowering pulmonary resistance, or have been using any of these medications in recent 3 months.
Key Trial Info
Start Date :
July 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04908657
Start Date
July 3 2017
End Date
December 31 2023
Last Update
June 8 2022
Active Locations (1)
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1
Department of Pediatrics, National Taiwan University Hospital
Taipei, Taiwan, 100