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Clinical Trials/NCT03133169
NCT03133169
Completed
Not Applicable

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

Assiut University1 site in 1 country80 target enrollmentJune 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thalassemia in Children
Sponsor
Assiut University
Enrollment
80
Locations
1
Primary Endpoint
Erythrocyte glutamine level
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
August 26, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Sami

Pediatric Resident

Assiut University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Erythrocyte glutamine level

Time Frame: 2 months

marker for oxidative stress

Tricuspid regurge velocity

Time Frame: 2 months

Measures the risk of pulmonary hypertension

Secondary Outcomes

  • Ferritin level(2 months)
  • Renal function tests(2 months)
  • Liver function tests(2 months)
  • Plasma glutamine level(2 months)

Study Sites (1)

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