NL-OMON24714尚未招募不适用
Prospective Randomized Trial of the Effects of Rosuvastatin on the Progression of Stenosis in Adult Patients with Congenital Aortic Stenosis.
Erasmus Medical Center, Rotterdam, Department of Cardiology0 个研究点目标入组 180 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Valvular congenital aortic stenosis with a maximum aortic jet velocity > 2.5 m/s;
- •2. Age 18-45 years.
排除标准
- •1. Use of statins or other study medication;
- •2. Subvalvular or supravalvular aortic stenosis;
- •3. Aortic regurgitation > 2+;
- •4. Malignancy within last 2 years;
- •5. Aortic valve replacement in past;
- •6. Rheumatic fever in past;
- •7. Significant concomitant mitral valve disease (MR > 2+ or MVA < 1.5 cm2);
- •8. Hhistory of HMG-CoA reductase inhibitor hypersensitivity;
- •9. Active liver disease;
- •10. Muscular/neuromuscular disease;
- •11. CPK > 3 x upper limit of normal (>600 U/L);
- •12. Renal impairment (creatinin > 200 umol/l);
- •13. Women contemplating pregnancy within next 5 years;
- •14. Pregnant/ breast-feeding women;
- •15. Women of childbearing potential not using appropriate contraception;
- •16. Use of ciclosporin.
研究者
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Prospective Randomized Trial of the Effects of Rosuvastatin on the Progression of Stenosis in Adult Patients with Congenital Aortic StenosisISRCTN56552248Erasmus Medical Center, Department of Cardiology (Netherlands)180
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