Status:
COMPLETED
Pulmonary Hypertension in Patients With Sickle Cell Disease in Nigeria
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Secondary Pulmonary Arterial Hypertension
Sickle Cell Disease
Eligibility:
All Genders
5+ years
Brief Summary
This study will explore how people with sickle cell disease (SCD) develop a complication called pulmonary hypertension (PHTN), a serious disease in which blood pressure in the lungs is higher than nor...
Detailed Description
Sickle cell disease (SCD) is an autosomal recessive disorder and the most common genetic disease in the world. SCD is the most common inherited blood disorder in the United States, affecting 70,000 to...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All volunteer subjects 5 years of age and above and able to provide informed, written consent for participation in this study. Children will be included in this study provided that a legally authorized representative provides fully informed consent. Assent of children will also be required.
- Inclusion Criteria for Volunteers with Sickle Cell:
- Nigerian male and females over 5 years of age
- Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or SBeta thalassemia or other genotype is required)
- Inclusion Criteria for Control Subjects:
- Nigerian males and females over 5 years of age.
- Electrophoretic documentation of hemoglobin A or AS genotype.
- EXCLUSION CRITERIA:
- Exclusion Criteria for Volunteers with Sickle Cell:
- Hb A-only phenotype and sickle cell trait
- Decisionally impaired subjects.
- Persons not able to understand the investigational nature of the study or give informed consent.
- Exclusion Criteria for Control Subjects:
- Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, SBeta thallassemia or other sickling genotype)
- Decisionally impaired subjects.
- Persons not able to understand the investigational nature of the study or give informed consent.
Exclusion
Key Trial Info
Start Date :
June 15 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00367523
Start Date
June 15 2006
End Date
September 28 2017
Last Update
November 29 2019
Active Locations (1)
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1
Ahmadu Bello University Teaching Hospital
Kaduna, Nigeria