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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00011648 |
Purpose
The purpose of this study is to determine how often people with sickle cell anemia develop pulmonary hypertension-a serious disease in which blood pressure in the artery to the lungs is elevated.
Men and women 18 years of age and older with sickle cell anemia may be eligible for this study. Participants will undergo an evaluation at Howard University's Comprehensive Sickle Cell Center in Washington, D.C. or at the National Institutes of Health in Bethesda, Maryland. It will include the following:
Following this evaluation, a study nurse will contact participants twice a month for 2 months and then once every 3 months for the next 3 years for a telephone interview. The interview will include questions about general health and recent health-related events, such as hospitalizations or emergency room visits.
| Condition |
|---|
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Pulmonary Hypertension Sickle Cell Anemia |
| Study Type: | Observational |
| Official Title: | Determining the Prevalence and Prognosis of Secondary Pulmonary Hypertension in Adult Patients With Sickle Cell Anemia |
| Estimated Enrollment: | 1100 |
| Study Start Date: | February 2001 |
Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease, and 8% have sickle cell trait. Acute pain crisis, acute chest syndrome (ACS), and secondary pulmonary hypertension are common complications of sickle cell anemia. Mortality rates of sickle cell patients with pulmonary hypertension are significantly increased as compared to patients without pulmonary hypertension. Recent studies report up to 40% mortality at 22 months after detection of elevated pulmonary artery pressures in sickle cell patients. Furthermore, pulmonary hypertension is thought to occur in up to 30% of clinic patients with sickle cell anemia.
This study is designed to determine the prevalence and prognosis of secondary pulmonary hypertension in adult patients with sickle cell anemia, and to determine whether genetic polymorphisms in candidate genes contribute to its development.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
All volunteer subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. Decisional impaired subjects will be included in this study provided that a legally authorized representative provides fully informed consent.
Sickle Cell Patients:
Male and females over 18 years of age.
Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S-beta thallassemia genotype is required).
EXCLUSION CRITERIA:
Sickle Cell Patients:
Hb A-only phenotype and sickle cell trait.
Decisionally impaired subjects without a legally authorized representative who are unable to have a next-of-kin surrogate appointed through the services of an ethics consult.
INCLUSION CRITERIA:
Control Subjects:
Male and females African American subjects over 18 years of age.
Exclusion of sickle cell disease (electrophoretic documentation of hemoglobin A is required).
EXCLUSION CRITERIA:
Control Subjects:
Diagnosis of sickle cell disease (electrophoretic documentation of SS, or SC, or SB thallassemia genotype is requird.
Decisionally impaired subjects without a legally authorized representative who are unable to have a next-of-kin surrogate appointed through the service of an ethics consult.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, District of Columbia | |
| Howard University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 010088, 01-H-0088 |
| Study First Received: | February 24, 2001 |
| Last Updated: | December 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00011648 |
| Health Authority: | United States: Federal Government |
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Echocardiogram Morbidity Mortality Sickle Cell Anemia Secondary Pulmonary Hypertension |
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Hematologic Diseases Anemia Vascular Diseases Anemia, Hemolytic Sickle cell anemia Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Respiratory Tract Diseases |
Hypertension, Pulmonary Hemoglobinopathies Lung Diseases Neoplasm Metastasis Secondary pulmonary hypertension Hemoglobinopathy Anemia, Sickle Cell Hypertension |
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Neoplasms Neoplastic Processes Pathologic Processes Cardiovascular Diseases |
