Clinical trial NCT03133169: Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children
Official title: Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children in Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia in Children
Pulmonary Hypertension
Hemolysis
Keywords: Thalassemia
Glutamine/glutamate ratio
Pulmonary hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Upper Egypt thalassemic children aged 10-18 years old attending Assiut University Children Hospital.

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


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.

Primary outcomes:
measure: Erythrocyte glutamine level
timeFrame: 2 months
measure: Tricuspid regurge velocity
timeFrame: 2 months
Secondary outcomes:
measure: Plasma glutamine level
timeFrame: 2 months
measure: Liver function tests
timeFrame: 2 months
measure: Renal function tests
timeFrame: 2 months
measure: Ferritin level
timeFrame: 2 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Children Hospital, Assiut University
name: Fahim M Fahim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children Hospital, Assiut University
name: Fatma S AbdElshafi, bachelor's
role: PRINCIPAL_INVESTIGATOR
affiliation: Children Hospital, Assiut University
name: Eman F. Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
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