Radboudumc
Nijmegen, The Netherlands, Netherlands
NCT Number: NCT05162742
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.
This study is active but is not currently recruiting participants.
50 year–80 year
All sexes
Interventional
Phase 3
Nijmegen, The Netherlands, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion Criterion:
Exclusion criteria
ATC: M04AC01
Placebo tablets
Time frame: Baseline and 24 months
Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC).
Time frame: Baseline and 24 months
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, 12 months and 24 months
Determined by change in peak velocity (m/s)
Time frame: Baseline and 24 months
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).
Radboud University Medical Center
Other
Does Colchicine Reduce Progression of Aortic Valve Stenosis?
Acronym: CHIANTI
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