NIH Clinical Research Studies

Protocol Number: 01-H-0088

Active Accrual, Protocols Recruiting New Patients

Title:
Determining the Prevalence and Prognosis of Secondary Pulmonary Hypertension in Adult Patients with Sickle Cell Anemia
Number:
01-H-0088
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, 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.

Sponsoring Institute:
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

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.

Special Instructions:
Currently Not Provided
Keywords:
Echocardiogram
Morbidity
Mortality
Recruitment Keyword(s):
Sickle Cell Anemia
Secondary Pulmonary Hypertension
Condition(s):
Pulmonary Hypertension
Sickle Cell Anemia
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Pulmonary hypertension and cor pulmonale in the sickle hemoglobinopathies

The acute chest syndrome in sickle cell disease: incidence and risk factors The Cooperative Study of Sickle Cell Disease

Systemic fat embolism and pulmonary hypertension in sickle cell disease

Active Accrual, Protocols Recruiting New Patients

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