Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00495638 |
The study will look at the risk factors for pulmonary hypertension (high blood pressure in the lungs) in children and adolescents with sickle cell anemia (SCA) and examine the role of hypoxia (oxygen shortage) in the disease. In patients with SCA, red blood cells become sickle-shaped and tend to form clumps that get stuck in blood vessels, blocking blood flow to the limbs and organs. Blocked blood vessels can cause pain, serious infections, and organ damage. Many patients with SCA also develop pulmonary hypertension.
Children and adolescents with SCA or Chuvash polycythemia (another blood disorder that carries an increased risk for pulmonary hypertension) may be eligible for this study.
Participants undergo the following procedures at the beginning (baseline) and end of the study:
In addition, patients are followed by telephone or by clinic visits every 6 months for a review of their medical history and medications. A physical examination is also done at 12 months.
...
Condition |
---|
Chuvash Polycythemia Cerebrovascular Disease Pulmonary Hypertension Sickle Cell Anemia |
Study Type: | Observational |
Official Title: | Pulmonary Hypertension and the Hypoxic Response in SCD |
Estimated Enrollment: | 1800 |
Study Start Date: | June 2007 |
The research is designed to determine the prevalence and risk factors of pulmonary hypertension (PHT) in children and adolescents with sickle cell disease (SCD), and to determine the role of the hypoxic response in its pathogenesis. In this regard, proliferative vascular responses mediated by (i) hypoxia inducible factor (HIF)-regulated pathways and (ii) nitric oxide (NO)-scavenging will be compared between patients with SCD and patients with Chuvash polycythemia (CP), another hematological disorder characterized by increased risk for PHT. High throughput microarray and genotyping technologies will be employed to identify candidate gene pholymorphisms involved in pathologic responses to hypoxia in SCD and CP patients with and without PHT.
Ages Eligible for Study: | 3 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
A. For PAH in children and adolescents with SCD:
Inclusion criteria for all participants:
Inclusion criteria for SCD patients:
Inclusion criteria for control participants:
EXCLUSION CRITERIA:
Exclusion criteria for all participants:
Exclusion criteria for SCD patients:
Exclusion criteria for control participants:
B. Angiogenic and vasomotor responses mediated by HIF-regulated pathways in patients with SCD and CP with and without PAH.
INCLUSION CRITERIA:
Inclusion criteria for all participants:
Inclusion criteria for SCD or CP patients with PAH:
Inclusion criteria for SCD or CP patients without PAH:
Inclusion criteria for control participants:
EXCLUSION CRITERIA:
Exclusion criteria for all participants:
Exclusion criteria for SCD or CP patients with PAH:
Exclusion criteria for SCD or CP patients without PAH:
Exclusion criteria for control participants:
C. High throughput microarray and genotyping technologies to identify candidate gene polymorphisms involved in pathologic responses to hypoxia in SCD and CP patients with PAH.
INCLUSION CRITERIA:
Inclusion criteria for all participants:
Inclusion criteria for SCD or CP patients with PAH:
Inclusion criteria for SCD or CP patients without PAH:
Inclusion criteria for screening for population prevalence of polymorphisms:
EXCLUSION CRITERIA:
Exclusion criteria for all participants:
Exclusion criteria for SCD or CP patients with PAH:
Exclusion criteria for SCD or CP patients without PAH:
Exclusion criteria for screening for population prevalence of polymorphisms
Contact: James Nichols, R.N. | (301) 435-2345 | jnichols@nih.gov |
United States, District of Columbia | |
Childrens National Medical Center | Recruiting |
Washington, District of Columbia, United States | |
Howard University Hospital | Recruiting |
Washington, District of Columbia, United States, 20060 | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0624 | |
Russian Federation, Chuvashia | |
Republic Cardiac Center | Recruiting |
Cheboksary, Chuvashia, Russian Federation, 428015 |
Study ID Numbers: | 999907181, 07-H-N181 |
Study First Received: | June 30, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00495638 |
Health Authority: | United States: Federal Government |
6-Minute Walk Chuvash Polycythemia Echocardiogram Sickle Cell Anemia |
Transcranial Doppler Sickle Cell Disease SCD Pulmonary Hypertension |
Polycythemia Hematologic Diseases Vascular Diseases Anemia Anemia, Hemolytic Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders Sickle cell anemia |
Anemia, Hemolytic, Congenital Respiratory Tract Diseases Genetic Diseases, Inborn Hypertension, Pulmonary Lung Diseases Hemoglobinopathies Hemoglobinopathy Anemia, Sickle Cell Hypertension |
Nervous System Diseases Cardiovascular Diseases |