N/A for Aortic valve stenosis | Aortic valve calcification | Aortic valve disease | Cardiovascular disease | Inflammation

Inclusion criteria

• {"criterion_text":"- Asymptomatic moderate aortic valve stenosis on recent (<6 months) echocardiography (based on aortic valve peak velocity, aortic valve mean pressure gradient, aortic valve area). The severity of AS will be quantified according to current EACVI / ASE guidelines."}

Exclusion criteria

• {"criterion_text":"- 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.).\n- Patients aged <50 and >80 years.\n- Pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance.\n- Child-bearing potential without the use of contraception.\n- Use of CYP3A4 (e.g. verapamil) or P-glycoprotein inhibitors.\n- Use of bisphosphonate or denosumab.\n- Chronic use of immunosuppressants or anti-inflammatory drugs including colchicine and NSAID's (excl. acetylsalicylic acid).\n- Active or chronic liver disease.\n- The presence of a pacemaker or internal cardiac defibrillator.\n- Life expectancy <2 years.\n- A planned aortic valve replacement in the next six months.\n- Severe mitral valve stenosis (MVA < 1cm2).\n- Severe mitral or aortic valve regurgitation.\n- Rheumatic aortic valve disease.\n- Bicuspid aortic valve.\n- Valvular disease due to history of chest radiation.\n- Left ventricular dysfunction (LVEF < 35%).\n- Renal impairment (eGFR <30 ml/min/1.73 m2)."}

Primary endpoints

• {"endpoint_text":"- The change in aortic valve calcium score measured by computed tomography (Agatston Units) at 24 months relative to baseline.","definition_or_measurement_approach":"Measured by computed tomography; change in Agatston Units at 24 months relative to baseline."}

Secondary endpoints

• {"endpoint_text":"- The change in 18F-NaF uptake of the aortic valve on positron emission tomography at 24 months relative to baseline.","definition_or_measurement_approach":"Measured by 18F-NaF PET imaging; change in tracer uptake at 24 months relative to baseline."}
• {"endpoint_text":"- The change in peak aortic jet velocity (m/s) measured by echocardiography at 24 months relative to baseline.","definition_or_measurement_approach":"Measured by echocardiography; change in peak aortic jet velocity (m/s) at 24 months relative to baseline."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-12-2024

Latest Decision Or Authorization Date

03-06-2025

Processing Time Days

182

Number Of Sites

2

Number Of Participants

150

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands