2024-513486-39-00
招募中
3 期
Does Colchicine Reduce Progression of Aortic Valve Stenosis? Colchicine and Inflammation in Aortic Stenosis (CHIANTI): A placebo-controlled, double-blind, multicenter randomized trial.
Stichting Radboud universitair medisch centrum2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Stichting Radboud universitair medisch centrum
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The change in aortic valve calcium score measured by computed tomography (Agatston Units) at 24 months relative to baseline.
概览
简要总结
To study the effect of colchicine treatment versus placebo on the progression of aortic valve stenosis in patients with moderate aortic valve stenosis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic moderate aortic valve stenosis on recent (<6 months) echocardiography (based on aortic valve peak velocity, aortic valve mean pressure gradient, aortic valve area). 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.).
- •Patients aged <50 and >80 years.
- •Pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance.
- •Child-bearing potential without the use of contraception.
- •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).
- •Active or chronic liver disease.
- •The presence of a pacemaker or internal cardiac defibrillator.
- •Life expectancy <2 years.
研究组 & 干预措施
Placebo Colchicine 0.5 mg tablets
Placebo
干预措施: Placebo Colchicine 0.5 mg tablets (Drug)
Colchicine Tiofarma 0,5 mg, tabletten
Test
干预措施: Colchicine Tiofarma 0,5 mg, tabletten (Drug)
结局指标
主要结局
The change in aortic valve calcium score measured by computed tomography (Agatston Units) at 24 months relative to baseline.
The change in aortic valve calcium score measured by computed tomography (Agatston Units) at 24 months relative to baseline.
次要结局
- The change in peak aortic jet velocity (m/s) measured by echocardiography at 24 months relative to baseline.
- The change in 18F-NaF uptake of the aortic valve on positron emission tomography at 24 months relative to baseline.
研究者
Saloua El Messaoudi, MD, PhD
Scientific
Stichting Radboud universitair medisch centrum
研究点 (2)
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