drugset / Trial / NCT05162742

Colchicine and Inflammation in Aortic Stenosis

NCT05162742

Phase 3 Active not recruiting 150 enrolled Radboud University Medical Center
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-12-22
Primary completion
2025-12-22
Completion
2025-12-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.5 mg