- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367523
Pulmonary Hypertension in Patients With Sickle Cell Disease in Nigeria
Prevalence of Secondary Arterial Hypertension (PAH) in Patients With Sickle Cell Disease in Nigeria and the Role of HIV/AIDS and Endemic Parasitic Infections in the Natural History of Pulmonary Hypertension in Sickle Cell Disease
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 normal. PHTN is also caused by HIV, hepatitis C and schistosomiasis. Patients who have both SCD and one of these other infections may develop more severe PHTN. The number of Nigerians with SCD who also have PHTN is not known, nor is the cause of PHTN in this population. This study will examine genetic material in people with and without SCD to determine whether certain genes will allow doctors to predict which patients with SCD are likely to develop PHTN.
Nigerian males and females 10 years of age and older with or without SCD may be eligible for this study. Patients must have SS, SC, or SB thalassemia or other genotype; control subjects must have hemoglobin A or AS genotype.
Participants undergo a complete medical history and physical examination, blood tests, electrocardiogram (EKG), ultrasound tests of the heart and abdomen, and a 6-minute walk (distance test) to determine exercise capacity. Blood tests include screening for HIV, hepatitis B and C, schistosomiasis, hookworm and malaria. Patients who test positive for HIV, hepatitis B or C, schistosomiasis, hookworm or malaria are referred for treatment at Ahmadu Bello University Teaching Hospital in Zaria, Nigeria, and those who test negative for hepatitis B are referred for vaccination. Genetic tests focus on genes involved in SCD, PHTN, inflammation, blood vessel function and red blood cell function.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kaduna, Nigeria
- Ahmadu Bello University Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Rother RP, Bell L, Hillmen P, Gladwin MT. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. JAMA. 2005 Apr 6;293(13):1653-62. doi: 10.1001/jama.293.13.1653.
- Aliyu ZY, Tumblin AR, Kato GJ. Current therapy of sickle cell disease. Haematologica. 2006 Jan;91(1):7-10. No abstract available.
- Morris CR, Kato GJ, Poljakovic M, Wang X, Blackwelder WC, Sachdev V, Hazen SL, Vichinsky EP, Morris SM Jr, Gladwin MT. Dysregulated arginine metabolism, hemolysis-associated pulmonary hypertension, and mortality in sickle cell disease. JAMA. 2005 Jul 6;294(1):81-90. doi: 10.1001/jama.294.1.81.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Neoplastic Processes
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Hypertension
- Neoplasm Metastasis
- Pulmonary Arterial Hypertension
- Anemia, Sickle Cell
- Hypertension, Pulmonary
Other Study ID Numbers
- 999906189
- 06-H-N189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica