NIH Clinical Center Search the Studies: Study Number, Study Title

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 | Eligibility | Citations | Contacts

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.

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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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Swee Lay Thein, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 6S241A
10 CENTER DR
BETHESDA MD 20892
(301) 402-6699
sweelay.thein@nih.gov

Nancy A. Asomaning
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 6S-241
10 Center Drive
Bethesda, Maryland 20892
(301) 827-8597
nancy.asomaning@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00011648

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NIH Clinical Center Search the Studies: Study Number, Study Title

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 | Eligibility | Citations | Contacts

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.

--Back to Top--

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


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Swee Lay Thein, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 6S241A
10 CENTER DR
BETHESDA MD 20892
(301) 402-6699
sweelay.thein@nih.gov

Nancy A. Asomaning
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 6S-241
10 Center Drive
Bethesda, Maryland 20892
(301) 827-8597
nancy.asomaning@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00011648

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