Does colchicine reduce progression of aortic valve stenosis?

Does colchicine reduce progression of aortic valve stenosis? - Colchicine and Inflammation in Aortic Stenosis (CHIANTI)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51747

Enrollment

150

Registered

2022-01-05

Start date

2022-12-22

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis narrowing of the aortic valve

Interventions

colchicine vs placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Asymptomatic moderate aortic valve stenosis. The severity of AS will be quantified according to current EACVI / ASE guidelines.

Exclusion criteria

Exclusion criteria: • Heavily calcified aortic valve on echocardiography (defined as grade 4 calcification: extensive thickening/calcification of all cusps as described in the articles by Rosenhek et al.). • Severe mitral valve stenosis (MVA 80 years. • Pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance. • The presence of a pacemaker or internal cardiac defibrillator. • Child-bearing potential without the use of contraception. • Renal impairment (eGFR

Design outcomes

Primary

Measure	Time frame
The change at 24 months relative to baseline in: - Aortic valve calcium score measured by computed tomography (Agatston Units).	—

Secondary

Measure	Time frame
The change at 24 months relative to baseline in: - 18F-NaF uptake of the aortic valve using positron emission tomography (PET). - Peak aortic-jet velocity (m/s determined by echocardiography).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)