Atorvastatin in Pulmonary Hypertension (APATH)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase

Completed

Phase 2

Conditions

Hypertension, Pulmonary

Treatments

Drug: Atorvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00615823

2005-1018 (Other Grant/Funding Number)

2006BAI01A07 (Other Grant/Funding Number)

2006-1152

Details and patient eligibility

About

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

Full 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 atorvastatin inhibits inflammation and has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal experiments. In addition, non-controlled clinical studies suggest that atorvastatin is effective and safe in patients with pulmonary hypertension.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety and efficacy of placebo and atorvastatin.

Enrollment

220 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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