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
1 other identifier
interventional
44
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2022
CompletedFirst Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2024
CompletedOctober 18, 2022
October 1, 2022
1 year
October 13, 2022
October 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary functions
change in the studied cardiopulmonary functions at the baseline and 3 months after intervention
3 months
Secondary Outcomes (3)
Biochemical parameters
3 months
Biochemical parameters
3 months
Biochemical parameters
3 months
Study Arms (2)
Group 1
ACTIVE COMPARATORn=22): Patients will receive traditional treatment and L- carnitine 50mg/kg/day orally (maximum dose 3g per day)
Group 2
ACTIVE COMPARATORn=22): Patients will receive traditional treatment and Sildenafil 0.25mg/kg/dose every 6 h orally (maximum dose 60 mg per day)
Interventions
l-carnitine stabilizes red blood cell membranes and thus improves the anemic state\[
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
You may qualify if:
- Children with Beta thalassemia major who have increased TRJV more than 2.5m/s.
- Children age from 6-18 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University Hospital
Tanta, Gharbia Governorate, 31511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sahar Kamal Hegazy, Professor
Tanta University
Central Study Contacts
Mostafa Zaki Zedan, Bsc of pharmaceutical science
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical pharmacist
Study Record Dates
First Submitted
October 13, 2022
First Posted
October 18, 2022
Study Start
July 8, 2022
Primary Completion
July 8, 2023
Study Completion
July 8, 2024
Last Updated
October 18, 2022
Record last verified: 2022-10