Skip to main content
OpenTrials
Completed

NCT Number: NCT03133169

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

The study will investigate the relation between erythrocyte glutamine/glutamate ratio and pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children Hospital

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thalassemia in Children Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hemolysis Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiratory Tract Diseases Thalassemia Vascular Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Diagnostic Test

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

Tricuspid regurge velocity

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.