Status:
COMPLETED
Atorvastatin in Pulmonary Hypertension
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborating Sponsors:
National Grant from The Ministry of Science and Technology
Capital Development Scientific Fund
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Ator...
Detailed Description
PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. Several research have proved that inflammation may participate in the pathogenesis of PAH. As atorvast...
Eligibility Criteria
Inclusion
- Able to understand and willing to sign the informed consent form
- \<=65 and \>=18years old
- Diagnosis of pulmonary arterial hypertension (Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary capillary wedge pressure less than 15 mm Hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism PAH in the absence of indications for surgery
- Patients in WHO functional class II to III
- Vasodilator Testing nonresponders
- Baseline six-minute walking distance between 100 and 460 m
Exclusion
- PAH related to other etiologies (Groups 2, 3 and 5 pulmonary hypertension)
- A forced expiratory volume in one second/ forced vital capacity bellow 50% or a total lung capacity of less than 60 percent predicted value
- A 6-minute walk distance of less than 100 or more than 460 m
- A positive acute vasodilator response
- Current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
- Inability to perform 6-minute walk test
- Serum transaminase level three times above the upper limit of normal
- Creatine kinase level five times above the upper limit of normal
- Previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
- History of transient ischemia attack or stroke within three months
- Bleeding disorder
- Positive pregnancy test or breastfeeding practice
- History or suspicion of inability to cooperate
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00615823
Start Date
February 1 2007
End Date
May 1 2010
Last Update
February 23 2012
Active Locations (1)
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1
Cardiovascular Institute and Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037