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ACTIVE NOT RECRUITING
NCT05162742
PHASE3

Colchicine and Inflammation in Aortic Stenosis

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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.

Official title: Does Colchicine Reduce Progression of Aortic Valve Stenosis?

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-12-22

Completion Date

2025-12-22

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DRUG

Colchicine

ATC: M04AC01

DRUG

Placebo

Placebo tablets

Locations (1)

Radboudumc

Nijmegen, The Netherlands, Netherlands