Status:
COMPLETED
Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate new treatments for people who have pulmonary hypertension, or high blood pressure in the lungs, caused by sickle cell anemia or thalassemia. Patients ages 18 and older with a...
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, ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Males or females, 18 years of age or older.
- Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S thalassemia genotype is required) or thalassemia.
- For female subjects, on a reliable method of birth control or not physically able to bear children.
- \<TAB\>
- For Stage II:
- Mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg during exercise, measured by pulmonary artery catheterization.
- Pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm Hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm Hg or echocardiographic criteria to exclude left ventricular dysfunction.
- For female subjects, on a reliable method of birth control or not physically able to bear children.
- For Stage III:
- Mild to severe pulmonary hypertension with mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg during exercise, measured by pulmonary artery catheterization in patients on chronic sildenafil therapy for at least three months. Patients receiving combination drug therapy with other drugs (e.g., endothelin antagonists, prostacyclins) are allowed to participate in stage III as long as sildenafil is one of the components of the combination regimen.
- Pulmonary artery wedge pressure or left ventricular end-diastolic pressure less than or equal to 18 mm Hg or gradient between pulmonary artery diastolic pressure and wedge pressure greater than 8 mm Hg or echocardiographic criteria to exclude left ventricular dysfunction.
- Must be on chronic sildenafil therapy on a stable dose for at least three months.
- For female subjects, on a reliable method of birth control or not physically able to bear children.
- EXCLUSION CRITERIA
- For Stage I
- Current pregnancy or lactation.
- Any condition that in the opinion of the study investigators would adversely affect the outcome of the study or the safety of the volunteer.
- For Stage II and III:
- Current pregnancy or lactation.
- Any of the following medical conditions
- Stroke within the last six weeks.
- History of sustained priapism requiring medical or surgical treatment, unless currently impotent or on exchange transfusion therapy, within two years.
Exclusion
Key Trial Info
Start Date :
July 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00352430
Start Date
July 9 2006
End Date
March 10 2010
Last Update
September 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892