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

Tanta University50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sickle Cell Disease

Interventions

L-ArginineDRUG

L-Arginine 1000 mg free form, rapid release capsules

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta university

Tanta, Other (Non U.s.), Egypt

Outcomes

Primary Outcomes

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

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

Time frame: 3 months

Secondary Outcomes

change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)

Blood samples will be collected at baseline and after 3 months

Time frame: 3 months

change in serum level of L-Arginine

Blood samples will be collected at baseline and after 3 months

Time frame: 3 months

change in serum level of Asymmetric Dimethyl Arginine (ADMA)

Blood samples will be collected at baseline and after 3 months

Time frame: 3 months

change in serum level of Nitric Oxide

Blood samples will be collected at baseline and after 3 months

Time frame: 3 months

Data from ClinicalTrials.gov

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