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Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial
EU CTIS ID: 2024-513486-39-00
What this study is testing
To study the effect of colchicine treatment versus placebo on the progression of aortic valve stenosis in patients with moderate aortic valve stenosis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.).
- 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.
See the full eligibility criteria
- 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.
- 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.).
- 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.
- 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/1.73 m2).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.