??Effect of intrapulmonary injection of stem cells in patients with pulmonary hypertention due to congenital heart defect whose heart disease has been repaired
Phase 1
- Conditions
- Eisenmenger's syndrome.other congenital malformation of cardiac septa
- Registration Number
- IRCT2017080435442N1
- Lead Sponsor
- Vice chancellor for research, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
operated VSD (ventricular septal defect) and pulmonary hypertension (Eisenmenger)? not improved pulmunary HTN 2years after surgery (despite recieving routine medical therapy)
Exclusion criteria: absence of consent? finding clot in heart? not tolerating catheterism
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary artery pressure. Timepoint: before intervention and 1month-3months-6months after procedure. Method of measurement: catheterism and echocardiography.;Pulmonary vascular resistance. Timepoint: before intervention and 1month-3months-6months after procedure. Method of measurement: catheterism and echocardiography.
- Secondary Outcome Measures
Name Time Method Right side cardiac output. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardiography and catheterism.;Patients' functional class. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: echocardigraphy and ECG and 6minutes walking test.;Results of 6 minute walking test. Timepoint: Before intervention and 1month-3months-6months after the procedure. Method of measurement: 6 minute walking test.