L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Study Details
Study Description
Brief Summary
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: control group this group will include 25 patients who will receive their standard therapy for 3 months |
|
Active Comparator: L-Arginine group this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months |
Drug: L-Arginine
L-Arginine 1000 mg free form, rapid release capsules
|
Outcome Measures
Primary Outcome Measures
- change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography [3 months]
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
Secondary Outcome Measures
- change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP) [3 months]
Blood samples will be collected at baseline and after 3 months
- change in serum level of L-Arginine [3 months]
Blood samples will be collected at baseline and after 3 months
- change in serum level of Asymmetric Dimethyl Arginine (ADMA) [3 months]
Blood samples will be collected at baseline and after 3 months
- change in serum level of Nitric Oxide [3 months]
Blood samples will be collected at baseline and after 3 months
Eligibility Criteria
Criteria
Inclusion Criteria:
-
children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
-
age 5-18 years
Exclusion Criteria:
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Another chronic hemolytic anemia.
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Patients with documented causes of pulmonary hypertension other than SCD.
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Allergy to L-arginine.
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Patients with Asthma.
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Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
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Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tanta university | Tanta | Other (Non U.s.) | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: dalia A gomaa, Tanta University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L-Arginine 2021