NCT05470998已完成3 期
Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
研究概览
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Active Comparator
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 (Drug)
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)
研究者
Dalia Abdelhamid Gomaa
demonstrator at clinical pharmacy department, faculty of pharmacy
Tanta University
研究点 (1)
Loading locations...
相似试验
已完成
4 期
L-Arginine and Erectile DysfunctionErectile DysfunctionNCT00777075Hannover Medical School57
尚未招募
不适用
Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum DisorderAutistic DisorderNCT06301685Muhammad80
终止
4 期
Effect of Chronic Supplementation of L-arginine in the Muscular PerformanceMuscular FatigueNCT00785811Sanofi36
已完成
2 期
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease PatientsAnemia, Sickle CellPneumoniaNCT00029731UCSF Benioff Children's Hospital Oakland30
尚未招募
不适用
Stellate Ganglion Block in Cerebral PalsyCerebral PalsyNCT06319508Copka Sonpashan80