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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05162742
Other study ID # 112719
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 22, 2022
Est. completion date December 22, 2025

Study information

Verified date May 2024
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 22, 2025
Est. primary completion date December 22, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criterion: • Asymptomatic moderate aortic valve stenosis on recent (<6 months) echocardiography (based on peak velocity, mean gradient, aortic valve area). The severity of AS will be quantified according to current EACVI / ASE guidelines. 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.); - a planned aortic valve replacement in the next six months; - severe mitral valve stenosis (MVA < 1cm2); - severe mitral or aortic valve regurgitation; - rheumatic aortic valve disease; - bicuspid aortic valve; - valvular disease due to history of chest radiation; - left ventricular dysfunction (LVEF < 35%); - renal impairment (eGFR <30 ml/min/1.73m2); - patients aged <50 and >80 years; - pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance; - child-bearing potential without the use of contraception; - use of CYP3A4 (e.g. verapamil) or P-glycoprotein inhibitors; - use of bisphosphonate or denosumab; - chronic use of immunosuppressants or anti-inflammatory drugs including colchicine and NSAID's (excl. acetylsalicylic acid); - active or chronic liver disease; - the presence of a pacemaker or internal cardiac defibrillator; - life expectancy <2 years.

Study Design


Intervention

Drug:
Colchicine
ATC: M04AC01
Placebo
Placebo tablets

Locations

Country Name City State
Netherlands Radboudumc Nijmegen The Netherlands

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in aortic valve calcium score Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC). Baseline and 24 months
Secondary Aortic valve 18F-NaF uptake Difference in aortic valve 18F-NaF uptake of the aortic valve using positron emission tomography (PET) between baseline and end of study. Baseline and 24 months
Secondary Change in echocardiographic parameter for aortic stenosis Determined by change in peak velocity (m/s) Baseline, 12 months and 24 months
Secondary Adverse Outcomes Determine the effect of colchicine on calcified aortic stenosis related adverse outcomes (cardiac death, myocardial infarction, stroke, (hospitalization for) heart failure and aortic valve replacement). Baseline and 24 months
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