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

• Status: Recruiting
• Trial end date: 2024-07-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Sildenafil Citrate

Criteria

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.