Using L-Arginine to treat children with Sickle Cell Disease and heart issues
Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
This study is testing if L-Arginine can help children with Sickle Cell Disease and heart issues feel better and improve their heart function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Other (Non U.s.)) |
| Trial ID | NCT05470998 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of L-Arginine in children aged 5 to 18 years who have Sickle Cell Disease and exhibit increased Tricuspid Regurgitant Jet Velocity. The intervention aims to assess whether L-Arginine can improve heart function and overall health in these patients. The study is interventional and is classified as a Phase 3 trial, indicating it is designed to confirm effectiveness and monitor side effects in a larger population.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years diagnosed with Sickle Cell Disease and increased Tricuspid Regurgitant Jet Velocity.
Not a fit: Patients with other chronic hemolytic anemias, documented pulmonary hypertension from causes other than Sickle Cell Disease, or those with allergies to L-Arginine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and quality of life for children suffering from Sickle Cell Disease.
How similar studies have performed: While this specific approach may be novel, similar studies exploring treatments for Sickle Cell Disease have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity * age 5-18 years Exclusion Criteria: * Another chronic hemolytic anemia. * Patients with documented causes of pulmonary hypertension other than SCD. * Allergy to L-arginine. * Patients with Asthma. * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) \> 3X upper value. * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Where this trial is running
Tanta, Other (Non U.s.)
- Tanta university — Tanta, Other (Non U.s.), Egypt (Recruiting)
Study contacts
- Principal investigator: dalia A gomaa — Tanta University
- Study coordinator: dalia A gomaa
- Email: dalia_gomaa@pharm.tanta.edu.eg
- Phone: 01063410525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.