Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Conditions
Brief summary
This study aims to investigate the possible efficacy and safety of L\_Carnitine and Sildenafil on patient with Beta thalassemia complicated with increased Tricuspid Regurgitant Jet Velocity
Interventions
DRUGL_carnitine
l-carnitine stabilizes red blood cell membranes and thus improves the anemic state\[
DRUGSildenafil
selective and potent inhibitor of cGMP-specific phosphodiesterase 5 (PDE5), which promotes smooth muscle relaxation in lung vasculature, has been used successfully in the treatment of primary and secondary PH.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children with Beta thalassemia major who have increased TRJV more than 2.5m/s. * Children age from 6-18 years
Exclusion criteria
* Others hemolytic anemia * Young age before 6 years of age * Allergy to Sildenafil or L-carnitine * Patient with documented causes of pulmonary hypertension rather than caused by Beta thalassemia. * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) 3X. * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary functions | 3 months | change in the studied cardiopulmonary functions at the baseline and 3 months after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical parameters | 3 months | Changes in Vascular Endothelial Growth Factor level (VEGF) at baseline and 3 months after the intervention |
Countries
Egypt
Contacts
Primary ContactMostafa Zaki Zedan, Bsc of pharmaceutical science
Outcome results
None listed