L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

Phase 3

Recruiting

• Conditions: Sickle Cell Disease
• Interventions: Drug: L-Arginine

• Registration Number: NCT05470998
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Arginine group	L-Arginine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Nitric Oxide	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

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Other (Non U.s.), Egypt