Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

Tanta University1 个研究点分布在 1 个国家目标入组 50 人2022年7月25日

适应症Sickle Cell Disease

干预措施L-Arginine

概览

阶段: 3 期
干预措施: L-Arginine
疾病 / 适应症: Sickle Cell Disease
发起方: Tanta University
入组人数: 50
试验地点: 1
主要终点: change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

注册库

clinicaltrials.gov

开始日期

2022年7月25日

结束日期

2024年10月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Tanta University

责任方

Principal Investigator

主要研究者

Dalia Abdelhamid Gomaa

demonstrator at clinical pharmacy department, faculty of pharmacy

Tanta University

入排标准

入选标准

•children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
•age 5-18 years

排除标准

•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.

研究组 & 干预措施

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

干预措施: L-Arginine

结局指标

主要结局

change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography

时间窗: 3 months

patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months

次要结局

change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)(3 months)
change in serum level of L-Arginine(3 months)
change in serum level of Nitric Oxide(3 months)
change in serum level of Asymmetric Dimethyl Arginine (ADMA)(3 months)