Clinical investigation into efficacy, haemodynamics and tolerability of simvastatin versus placebo in patients with pulmonary arterial hypertensio

niversity Hospital Giessen (Germany)0 个研究点目标入组 40 人开始时间: 2006年6月14日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Female and male patients of any racial origin with pulmonary hypertension (PH)
•2. Having fulfilled his/her 18th birthday on day 1 of the study
•3. Modified New York Heart Association (NYHA) class II or III
•4. PH due to idiopathic pulmonary arterial hypertension or collagen vascular disease associated PH
•5. Cardiac catheterisation within the last year consistent with PH, specifically pulmonary artery mean pressure (PAPM) greater than or equal to 25 mmHg (at rest), pulmonary capillary wedge pressure (PCWP) (or left ventricular [LV] end diastolic pressure) less than or equal to 15 mmHg, and peripheral vascular resistance (PVR) greater than 3 mmHg/l/min
•6. Echocardiogram on day 1 consistent with PH, more specifically, evidence of right ventricular hypertrophy or dilation, evidence of normal left ventricular function, and absence of mitral valve stenosis
•7. Six-minute walk test between 150 and 450 m
•8. Patients receiving conventional PH therapy. Stable for one month.
•9. Able to understand and willing to sign the informed consent form
•10. Negative pregnancy test (ß-human chorionic gonadotropin [HCG]) at the start of the trial and appropriate contraception throughout the study for women of child-bearing potential

•1. Pregnancy and/or lactation
•2. PH of any cause other than permitted in the entry criteria
•3. Contraindication for cardiac magnetic resonance (CMR) scan or heart catheterisation
•4. Any change in disease-targeted therapy within the last four weeks
•5. Patients requiring prostanoid therapy at the start of the study
•6. Patients already taking a statin
•7. Any subject who has received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
•8. Known intolerance to hydroxy-methylglutaryl coenzyme A (HMG-CoA)-inhibitors (statins) or any of the excipients
•9. Active liver disease, porphyria or elevations of serums transaminases greater than three times upper limit of normal (ULN) or bilirubin greater than 1.5 x ULN
•10. Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, human immunodeficiency virus [HIV] protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone, ciclosporin and danazole)
•11. History or suspicion of inability to cooperate adequately

发起方

niversity Hospital Giessen (Germany)