Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
NCT ID: NCT05584956
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
44 participants
INTERVENTIONAL
2022-07-08
2024-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
n=22): Patients will receive traditional treatment and L- carnitine 50mg/kg/day orally (maximum dose 3g per day)
L_carnitine
l-carnitine stabilizes red blood cell membranes and thus improves the anemic state\[
Group 2
n=22): Patients will receive traditional treatment and Sildenafil 0.25mg/kg/dose every 6 h orally (maximum dose 60 mg per day)
Sildenafil
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.
Interventions
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L_carnitine
l-carnitine stabilizes red blood cell membranes and thus improves the anemic state\[
Sildenafil
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.
Eligibility Criteria
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Inclusion Criteria
* Children age from 6-18 years
Exclusion Criteria
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mostafa Zaki Zedan
Clinical pharmacist
Principal Investigators
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Sahar Kamal Hegazy, Professor
Role: PRINCIPAL_INVESTIGATOR
Tanta University
Locations
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Tanta University Hospital
Tanta, Gharbia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mohamed Ramadan El_shanshory, Professor
Role: primary
Other Identifiers
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Beta thalassemia
Identifier Type: -
Identifier Source: org_study_id
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