Atorvastatin in Pulmonary Hypertension

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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 Atorvastatin

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Capital Development Scientific Fund; National Grant from The Ministry of Science and Technology
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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