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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03133169
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Fatma Sami, 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

Condition or disease Intervention/treatment
Thalassemia in Children Pulmonary Hypertension Hemolysis Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children in Assiut University Children Hospital
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 25, 2019
Actual Study Completion Date : August 26, 2019


Group/Cohort Intervention/treatment
on chelation

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

Diagnostic Test: blood sample
blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level

Diagnostic Test: Tricuspid regurge velocity
Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children

No chelation

group 2: cases without chelation

Diagnostic Test: blood sample

Diagnostic Test: Tricuspid regurge velocity

Diagnostic Test: blood sample
blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level

Diagnostic Test: Tricuspid regurge velocity
Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children

splenectomy

group 3: cases with splenectomy

Diagnostic Test: blood sample

Diagnostic Test: Tricuspid regurge velocity

Diagnostic Test: blood sample
blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level

Diagnostic Test: Tricuspid regurge velocity
Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children

no splenectomy
group 4: cases without splenectomy Diagnostic Test: blood sample Diagnostic Test: Tricuspid regurge velocity
Diagnostic Test: blood sample
blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level

Diagnostic Test: Tricuspid regurge velocity
Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children




Primary Outcome Measures :
  1. Erythrocyte glutamine level [ Time Frame: 2 months ]
    marker for oxidative stress

  2. Tricuspid regurge velocity [ Time Frame: 2 months ]
    Measures the risk of pulmonary hypertension


Secondary Outcome Measures :
  1. Plasma glutamine level [ Time Frame: 2 months ]
    Assess the glutamine level at each visit

  2. Liver function tests [ Time Frame: 2 months ]
    Evaluates the state of liver

  3. Renal function tests [ Time Frame: 2 months ]
    Evaluates the state of kidney

  4. Ferritin level [ Time Frame: 2 months ]
    measuring the iron overload


Biospecimen Retention:   Samples Without DNA
Plasma sample


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Upper Egypt thalassemic children aged 10-18 years old attending Assiut University Children Hospital.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133169


Locations
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Egypt
Assiut University
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Fahim M Fahim, PhD Children Hospital, Assiut University
Principal Investigator: Fatma S AbdElshafi, bachelor's Children Hospital, Assiut University
Principal Investigator: Eman F. Mohamed, PhD Children Hospital, Assiut University

Publications:

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Responsible Party: Fatma Sami, Pediatric Resident, Assiut University
ClinicalTrials.gov Identifier: NCT03133169    
Other Study ID Numbers: GlnThalassemia
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatma Sami, Assiut University:
Thalassemia
Glutamine/glutamate ratio
Pulmonary hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Thalassemia
beta-Thalassemia
Hemolysis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes