Status:
COMPLETED
Heart Disease in Sickle Cell Anemia
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Sickle Cell Anemia
Pulmonary Hypertension
Eligibility:
All Genders
18-60 years
Brief Summary
This study will explore what may cause people with sickle cell anemia to have heart problems and an increased risk of sudden death. People 18 years of age and older with sickle cell anemia may be eli...
Detailed Description
Sickle cell anemia is an inherited blood disorder primarily affecting groups with origins in endemic malarial areas, especially those of African descent. SCA results from one of two single amino-acid ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA FOR RIGHT HEART CATHETERIZATION AND STRESS ECHO:
- Either gender, aged greater than 18 years
- Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S Beta-thalassemia genotype is required)
- Hematocrit greater than 18 % (with an absolute reticulocyte count greater than 100,000/ml)
- EXCLUSION CRITERIA FOR RIGHT HEART CATHETERIZATION AND STRESS ECHO:
- Pregnancy or lactation
- Known or suspected coronary artery disease
- Hematocrit less than 18 %: will not be eligible for the study; may return for evaluation at a later date
- Significant renal insufficiency (patient on hemodialysis or estimated creatinine clearance less than 30% of normal
- Cerebrovascular accident within the last six weeks
- New diagnosis of pulmonary embolism within the last three months
- History of retinal detachment
- Patients with PAH known to be secondary to other causes, such as systemic lupus erythematosus, other collagen vascular diseases, valvular heart disease, congenital heart disease
- Poor echo windows
- Any other condition that would prevent participation in the study (for example HIV infection)
- INCLUSION CRITERIA FOR NON-INVASIVE PROCEDURES:
- Either gender, aged greater than 18 years
- Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S Beta-thalassemia genotype is required)
- EXCLUSION CRITERIA FOR NON-INVASIVE PROCEDURES:
- Pregnancy or lactation
- Known or suspected coronary artery disease
- Significant renal insufficiency (patient on hemodialysis or estimated creatinine clearance less than 30%of normal
- Cerebrovascular accident within the last six weeks
- New diagnosis of pulmonary embolism within the last three months
- History of retinal detachment
- Patients with PAH known to be secondary to other causes, such as systemic lupus erythematosus, other collagen vascular diseases, valvular heart disease, congenital heart disease
- Patients who are intolerant of MRI will not undergo cardiac MRI
- Any other condition that would prevent participation in the study (for example HIV infection)
Exclusion
Key Trial Info
Start Date :
June 2 2005
Trial Type :
OBSERVATIONAL
End Date :
October 2 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00113152
Start Date
June 2 2005
End Date
October 2 2007
Last Update
July 2 2017
Active Locations (2)
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1
Suburban Hospital
Bethesda, Maryland, United States, 20814
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892