Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%. Once at an advanced stage, AS will lead to the development of left ventricle hypertrophy, and eventually heart failure and death. At-present, there is no effective medical therapy for aortic stenosis. Current management of patients with AS consists of 'watchful waiting'. Valve replacement is needed when these patients (often acutely) become symptomatic. Recent studies have shown that inflammatory processes with similarities to atherosclerosis play an important role in AS. Therefore, we hypothesize that treatment with anti-inflammatory therapy, in the form of colchicine, could reduce the progression of AS. If positive, this trial will be the first to provide a potential therapeutic option for millions of people world-wide with AS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
ATC: M04AC01
Placebo tablets
Radboudumc
Nijmegen, The Netherlands, Netherlands
Change in aortic valve calcium score
Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC).
Time frame: Baseline and 24 months
Aortic valve 18F-NaF uptake
Difference in aortic valve 18F-NaF uptake of the aortic valve using positron emission tomography (PET) between baseline and end of study.
Time frame: Baseline and 24 months
Change in echocardiographic parameter for aortic stenosis
Determined by change in peak velocity (m/s)
Time frame: Baseline, 12 months and 24 months
Adverse Outcomes
Determine the effect of colchicine on calcified aortic stenosis related adverse outcomes (cardiac death, myocardial infarction, stroke, (hospitalization for) heart failure and aortic valve replacement).
Time frame: Baseline and 24 months
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