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

Completed

• Conditions: Thalassemia in Children; Hemolysis; Pulmonary Hypertension
• Interventions: Diagnostic Test: blood sample; Diagnostic Test: Tricuspid regurge velocity

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No chelation	blood sample	group 2: cases without chelation Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
no splenectomy	Tricuspid regurge velocity	group 4: cases without splenectomy Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
on chelation	blood sample	patients with B-thalassemia major samples of which will be examined for renal and liver function, Erythrocyte Glutamine level, ferritin level and complete blood picture. Also Echo will be done for measuring the Tricuspid regurge velocity. group 1: cases on chelation: deferasirox 500mg oral tablet with initial dose 20 mg/kg guided by ferritin level Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
splenectomy	Tricuspid regurge velocity	group 3: cases with splenectomy Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
no splenectomy	blood sample	group 4: cases without splenectomy Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
on chelation	Tricuspid regurge velocity	patients with B-thalassemia major samples of which will be examined for renal and liver function, Erythrocyte Glutamine level, ferritin level and complete blood picture. Also Echo will be done for measuring the Tricuspid regurge velocity. group 1: cases on chelation: deferasirox 500mg oral tablet with initial dose 20 mg/kg guided by ferritin level Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
No chelation	Tricuspid regurge velocity	group 2: cases without chelation Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
splenectomy	blood sample	group 3: cases with splenectomy Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity

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