Protocol Details
Determining the Prevalence and Prognosis of Secondary Pulmonary Hypertension in Adult Patients with Sickle Cell Anemia
This study is NOT currently recruiting participants.
Summary
Number |
01-H-0088 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Echocardiogram;
Morbidity;
Mortality;
Natural History |
Recruitment Keyword(s) |
Sickle Cell Anemia;
Secondary Pulmonary Hypertension |
Condition(s) |
Pulmonary Hypertension;
Sickle Cell Anemia;
Sickle Cell Disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Diabetes and Digestive and Kidney DiseasesNational Heart, Lung, and Blood Institute |
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:
-medical history
-physical examination
-blood collection (no more than 50 ml., or about 1/3 cup) to confirm the diagnosis of sickle cell anemia, sickle cell trait or beta-thalassemia (Some blood will be stored for future research testing on sickle cell anemia.)
-echocardiogram (ultrasound test of the heart) to check the pumping action of the heart and the rate at which blood travels through the tricuspid valve.
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.
Eligibility
INCLUSION CRITERIA FOR 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 FOR SICKLE CELL PATIENTS:
-Hb A-only phenotype and sickle cell trait.
-Decisionally impaired subjects.
-Pregnant or lactating women
INCLUSION CRITERIA FOR 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 FOR CONTROL SUBJECTS:
-Diagnosis of sickle cell disease (electrophoretic documentation of SS, or SC, or SB thallassemia genotype is required.)
-Decisionally impaired subjects.
-Pregnant or lactating women
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT00011648