Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Arterial Hypertension: double-blinded, randomised, prospective phase III-b study for 12 weeks with adjusted doses of atorvastatin (40 - 80 mg daily)

Completed

• Conditions: Hypertension; Pulmonary hypertension; Circulatory System

• Registration Number: ISRCTN63558875
• Lead Sponsor: niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Female and male patients of any racial origin with pulmonary arterial hypertension (PAH)
2. Having fulfilled his/her 18th birthday on day one of the study
3. Modified New York Heart Association (NYHA) functional class II and III
4. Unencouraged six minute walking distance at baseline less than 500 m
5. Symptomatic PAH due to idiopathic or familial PAH or associated with corrected congenital systemic-to-pulmonary shunts, drugs, toxins and collagen tissue disease (scleroderma, mixed collagenosis)
6. PAH diagnosed by right heart catheter showing:
6.1. Mean pulmonary arterial pressure (mPAP) more than 25 mmHg
6.2. Pulmonary capillary wedge pressure (PCWP) less than 15 mmHg
6.3. Pulmonary vascular resistance (PVR) at baseline of more than 320 dyne*sec/cm^5
7. Patient stable for at least eight weeks before enrolment
8. Able to understand and willing to sign the informed consent form
9. Negative pregnancy test at the start of the trial and highly effective contraception (oral or injectable contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomised partner) throughout the study for women with child-bearing potential

Exclusion Criteria

1. Pregnancy and/or lactation
2. Women of child-bearing potential not using appropriate contraceptive measures
3. PAH of any cause other than permitted in the entry criteria
4. Suspected pulmonary veno-occlusive disease based on pulmonary oedema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary oedema at high resolution computer tomography)
5. Myopathy
6. Any change in disease-targeted therapy and calcium-channel-blockers within the last four weeks
7. Patients already taking a statin or fibrates
8. Any subject who had received any investigational medication within one month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
9. Known hypersensitivity to hydroxymethylglutaryl-coenzyme A (HMG-CoA)-inhibitors (statins) or any of the excipients
10. Active liver disease or unexplained persistent elevations of serums transaminases, gamma-glutamyl transpeptidase (gGT), alkaline phosphatase (AP) more than three x upper limit of normal (ULN) and elevations of creatine kinase (CK) more than two x ULN
11. History or suspicion of inability to cooperate adequately
12. Systolic blood pressure less than 85 mmHg
13. Body weight less than 40 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six minute walk test after 12 weeks of treatment compared to baseline.

Secondary Outcome Measures

Name	Time	Method
1. Short Form health survey (SF-36) <br>2. Borg scale <br>3. Modified NYHA class<br>4. Laboratory parameters<br>5. Adverse events<br>6. Concomitant medication