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Active, Not Recruiting

NCT Number: NCT05162742

Colchicine and Inflammation in Aortic Stenosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine

Drug

ATC: M04AC01

Placebo

Drug

Placebo tablets

Primary outcomes

  1. Change in aortic valve calcium score

    Time frame: Baseline and 24 months

    Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC).

Secondary outcomes

  1. Aortic valve 18F-NaF uptake

    Time frame: Baseline and 24 months

    Difference in aortic valve 18F-NaF uptake of the aortic valve using positron emission tomography (PET) between baseline and end of study.

  2. Change in echocardiographic parameter for aortic stenosis

    Time frame: Baseline, 12 months and 24 months

    Determined by change in peak velocity (m/s)

  3. Adverse Outcomes

    Time frame: Baseline and 24 months

    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).

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Does Colchicine Reduce Progression of Aortic Valve Stenosis?

Acronym: CHIANTI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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