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Erythrocyte Glutamine/Glutamate Ratio Relation to Pulmonary Hypertension Risk in Thalassemic Children

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ClinicalTrials.gov Identifier: NCT03133169
Recruitment Status : Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
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: Erythrocyte glutamine/glutamate ratio Diagnostic Test: Tricuspid regurge velocity

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Erythrocyte Glutamine/Glutamate Ratio Relation to Pulmonary Hypertension Risk in Thalassemic Children in Assiut University Children Hospital
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Thalassemic patients
They will be investigated for erythrocyte glutamine/glutamate ratio and Tricuspid regurge velocity
Diagnostic Test: Erythrocyte glutamine/glutamate ratio
Erythrocyte glutamine/glutamate ratio is a biomarker of oxidative stress. Will be obtained through examination of a blood sample

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/glutamate ratio [ Time Frame: 2 months ]
    Biological 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



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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


Contacts
Contact: Fatma S AbdElshafi, bachelor's 00201067116569 Fatma.s.hamdan@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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:

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

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:
Hypertension
Hypertension, Pulmonary
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