Impact of sildenafil on the ventriculo-arterial performance in fontan palliated patients
Not Applicable
- Conditions
- congenital heart disease circulatory disease.Other functional disturbances following cardiac surgery
- Registration Number
- IRCT201202209092N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
patients aged =8 years with Fontan modification of ECTCPC, patients had NYHA function class of I , being stable for the past 6 months without the occurrence of new symptoms or any changes in their medication.
Exclusion criteria: pulse oxymetry of <80%, systolic blood pressure of <75 mmHg, hepatic and renal dysfunction confirmed by laboratory examination, ophthalmic and auditory defect, hypersensivity to sildenafil, Fontan pathway obstruction detected by CT/MR imaging or angiography and recent use of sildenafi in the past 3 months, patients with residual cardiovascular defects such as coarctation, cardiac dysrhythmia or bradycardia, pregnant patients
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Elastance. Timepoint: at the onset and one week post sildenafil administration. Method of measurement: echocardiography.
- Secondary Outcome Measures
Name Time Method Headache, flushing,vertigo,nausea and vomiting, abdominal pain, renal stone, photosensivity,rash,diarrhea ,hypotension, musle pain,tinnitus. Timepoint: at the onset and one week post sildenafil administration and surviellance of side effects during the one week period of study. Method of measurement: queries.