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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Active Comparator | 75 patients will receive colchicine tablets |
|
| Placebo | Placebo Comparator | 75 patients will receive placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | ATC: M04AC01 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aortic valve calcium score | Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC). | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 months |
| Change in echocardiographic parameter for aortic stenosis |
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Inclusion Criterion:
• Asymptomatic moderate aortic valve stenosis on recent (<6 months) echocardiography (based on peak velocity, mean gradient, aortic valve area). The severity of AS will be quantified according to current EACVI / ASE guidelines.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | The Netherlands | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40659197 | Derived | Mohammadnia N, Vestjens LTW, Craig NJ, Tijssen JGP, Knol RJJ, Lazarenko SV, Duffels MGJ, Jaspers Focks J, Hemels MEW, Oving I, Schalkx HJ, Eikelboom JW, Cetinyurek-Yavuz A, Aarntzen EHJG, Dey D, Slomka PJ, Nijveldt R, Riksen NP, van Royen N, Honigberg MC, Dweck MR, Cornel JH, El Messaoudi S. The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial. Am Heart J. 2025 Dec;290:297-309. doi: 10.1016/j.ahj.2025.07.010. Epub 2025 Jul 12. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| C562942 | Aortic Valve, Calcification of |
| D007249 | Inflammation |
| D002114 | Calcinosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo tablets |
|
Determined by change in peak velocity (m/s)
| 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). | Baseline and 24 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |