Trial record 5 of 34 for:    pulmonary hypertension and sickle cell

Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00011648
First received: February 24, 2001
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition
Pulmonary Hypertension
Sickle Cell Anemia
Sickle Cell Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Determining the Prevalence and Prognosis of Secondary Pulmonary Hypertension in Adult Patients With Sickle Cell Anemia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine the prevalence and prognosis of secondary pulmonary hypertension in adult patients with sickle cell anemia. [ Time Frame: 10 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether genetic polymorphisms in candidate genes contribute to its development or response to treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: February 2001
Detailed Description:

Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 not be included in this study because it does not offer the prospect of direct benefit.

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.

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 required.

Decisionally impaired subjects.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011648

Contacts
Contact: Darlene T Allen (301) 435-1495 darlenea@mail.nih.gov
Contact: James G Taylor, M.D. (301) 435-7895 jamesta@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: James G Taylor, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00011648     History of Changes
Other Study ID Numbers: 010088, 01-H-0088
Study First Received: February 24, 2001
Last Updated: August 29, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Echocardiogram
Morbidity
Mortality
Sickle Cell Anemia
Secondary Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Anemia, Sickle Cell
Lung Diseases
Anemia
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014