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

Phase 3

Recruiting

• Conditions: Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
• Interventions: Drug: L_carnitine; Drug: Sildenafil

• Registration Number: NCT05584956
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Status Verified: 2022-10
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18
• Primary Completion: 2023-07-08
• Study Completion: 2024-07-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	L_carnitine	n=22): Patients will receive traditional treatment and L- carnitine 50mg/kg/day orally (maximum dose 3g per day)
Group 2	Sildenafil	n=22): Patients will receive traditional treatment and Sildenafil 0.25mg/kg/dose every 6 h orally (maximum dose 60 mg per day)

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary functions	3 months	change in the studied cardiopulmonary functions at the baseline and 3 months after intervention

Secondary Outcome Measures

Name	Time	Method
Biochemical parameters	3 months	Changes in ferritin serum level at the baseline and 3 months after the intervention

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Gharbia, Egypt