Clinical Trial

Colchicine and Inflammation in Aortic Stenosis

Study acronym: CHIANTI
Active, Not Recruiting Phase 3
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Record status
This record was last updated September 11, 2025 (before its estimated December 22, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-06; most recent amendment 2025-09-04.
Status change: Recruiting → Active, Not Recruiting 2025-03-03
Status change: Not Yet Recruiting → Recruiting 2022-06-16
Trial Details
NCT Number NCT05162742
Lead Sponsor Radboud University Medical Center
Conditions Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation, Calcification, Cardiovascular Diseases
Enrollment 150 participants
Start Date 2022-12-22
Primary Completion 2025-12-22 (estimated)
Study Completion 2025-12-22 (estimated)
Updated on ClinicalTrials.gov 2025-09-11