Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011648
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2001-02-24
Brief Title:
Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Determining the Prevalence and Prognosis of Secondary Pulmonary Hypertension in Adult Patients With Sickle Cell Anemia
Status:
COMPLETED
Status Verified Date:
2024-08-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 DC 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 13 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
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 DC 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 13 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
Detailed Description:
Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans Approximately 015 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 or response to treatment
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 or response to treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-H-0088 | None | None | None |