NL-OMON51747招募中3 期
Does colchicine reduce progression of aortic valve stenosis? - Colchicine and Inflammation in Aortic Stenosis (CHIANTI)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Asymptomatic moderate aortic valve stenosis. The severity of AS will be
- •quantified according to current EACVI / ASE guidelines.
排除标准
- •Heavily calcified aortic valve on echocardiography (defined as grade 4
- •calcification: extensive thickening/calcification of all cusps as described in
- •the articles by Rosenhek et al.).
- •Severe mitral valve stenosis (MVA < 1cm2).
- •Severe mitral or aortic valve regurgitation.
- •Left ventricular dysfunction (LVEF < 35%).
- •Bicuspid aortic valve.
- •Rheumatic aortic valve disease.
- •Valvular disease due to history of chest radiation.
- •Patients aged <50 and >80 years.
- •Pre-existing chronic gastro-intestinal complaints which may obscure signs of
- •colchicine intolerance.
- •The presence of a pacemaker or internal cardiac defibrillator.
- •Child-bearing potential without the use of contraception.
- •Renal impairment (eGFR <30 ml/min/1.73m2).
- •Active or chronic liver disease.
- •A planned aortic valve replacement in the next six months.
- •Use of CYP3A4 (e.g. verapamil) or P-glycoprotein inhibitors.
- •Use of bisphosphonate or denosumab.
- •Chronic use of immunosuppressants or anti-inflammatory drugs including
- •colchicine and NSAID*s (excl. acetylsalicylic acid).
- •Life expectancy <2 years.
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