Trials / Active Not Recruiting
Active Not RecruitingNCT05162742
Colchicine and Inflammation in Aortic Stenosis
Does Colchicine Reduce Progression of Aortic Valve Stenosis?
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Aortic Valve Disease
- Aortic Valve Stenosis
- Aortic Valve Calcification
- Inflammation
- Calcification
- Cardiovascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Colchicine | ATC: M04AC01 |
| DRUG | Placebo | Placebo tablets |
Timeline
- Start date
- 2022-12-22
- Primary completion
- 2025-12-22
- Completion
- 2025-12-22
- First posted
- 2021-12-17
- Last updated
- 2025-09-11
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05162742. Inclusion in this directory is not an endorsement.