Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children

Completed

• Conditions: Thalassemia in Children; Hemolysis; Pulmonary Hypertension

• Registration Number: NCT03133169
• Lead Sponsor: Assiut University

Brief Summary

The study will investigate the relation between erythrocyte glutamine/glutamate ratio and pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children Hospital

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-15
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2017-06-01
• Status Verified: 2019-08
• Primary Completion: 2019-08-25
• Study Completion: 2019-08-26
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Established diagnosis of Thalassemia.
• PH risk documented by doppler echocardiography, defined as tricuspid regurge velocity (TRV) equal to or greater than 2.5 m/s

Exclusion Criteria

• Acute crisis or hospitalization within 1 month of enrollment
• Hepatic dysfunction (SGPT greater than 3X normal)
• Renal dysfunction (Creatinine greater than 2X normal)
• Patients on sildenafil (Viagra), calcium channel blockers or other drugs for the control of PH.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erythrocyte glutamine level	2 months	marker for oxidative stress
Tricuspid regurge velocity	2 months	Measures the risk of pulmonary hypertension

Secondary Outcome Measures

Name	Time	Method
Renal function tests	2 months	Evaluates the state of kidney
Liver function tests	2 months	Evaluates the state of liver
Ferritin level	2 months	measuring the iron overload
Plasma glutamine level	2 months	Assess the glutamine level at each visit

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt