Aortic Valve DiseasePhase 3CHIANTINCT05162742
Colchicine and Inflammation in Aortic Stenosis
A Phase 3 study testing Colchicine in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2022to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Colchicine Reduce Progression of Aortic Valve 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.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation, Calcification, Cardiovascular Diseases
- Being tested
- Colchicine, Placebo
- Keywords
- Aortic Stenosis, Inflammation
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of, Inflammation, Calcinosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
ATC: M04AC01
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | 75 patients will receive colchicine tablets Receives: Drug: Colchicine |
| Placebo | Placebo comparator | 75 patients will receive placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic valve calcium score
Change in aortic valve calcium score measured by computed tomography aortic valve calcification (CT-AVC).
Measured: Baseline and 24 months
Secondary outcomes (3)
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.
Measured: Baseline and 24 months
Change in echocardiographic parameter for aortic stenosis
Determined by change in peak velocity (m/s)
Measured: Baseline, 12 months and 24 months
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).
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start22 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162742
- Sponsor's protocol ID
- 112719
- Acronym
- CHIANTI
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohammadnia N, Vestjens LTW, Craig NJ, Tijssen JGP, Knol RJJ, Lazarenko SV, Duffels MGJ, Jaspers Focks J, Hemels MEW, Oving I, Schalkx HJ, Eikelboom JW, Cetinyurek-Yavuz A, Aarntzen EHJG, Dey D, Slomka PJ, Nijveldt R, Riksen NP, van Royen N, Honigberg MC, Dweck MR, Cornel JH, El Messaoudi S. The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial. Am Heart J. 2025 Dec;290:297-309. doi: 10.1016/j.ahj.2025.07.010. Epub 2025 Jul 12.
PubMed 40659197
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Colchicine Reduce Progression of Aortic Valve Stenosis?
- ClinicalTrials.gov ID
- NCT05162742
- Acronym / sponsor ID
- CHIANTI / 112719
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation, Calcification, Cardiovascular Diseases
- Keywords
- Aortic Stenosis, Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine75 patients will receive colchicine tablets |
| Placebo | Placebo comparator | Drug: Placebo75 patients will receive placebo tablets |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineATC: M04AC01 | Drug | Colchicine |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
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).
3 secondary outcomes
Aortic valve 18F-NaF uptake
Time frame: Baseline and 24 months
Change in echocardiographic parameter for aortic stenosis
Time frame: Baseline, 12 months and 24 months
Adverse Outcomes
Time frame: Baseline and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40659197Mohammadnia N, Vestjens LTW, Craig NJ, Tijssen JGP, Knol RJJ, Lazarenko SV, Duffels MGJ, Jaspers Focks J, Hemels MEW, Oving I, Schalkx HJ, Eikelboom JW, Cetinyurek-Yavuz A, Aarntzen EHJG, Dey D, Slomka PJ, Nijveldt R, Riksen NP, van Royen N, Honigberg MC, Dweck MR, Cornel JH, El Messaoudi S. The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial. Am Heart J. 2025 Dec;290:297-309. doi: 10.1016/j.ahj.2025.07.010. Epub 2025 Jul 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aortic valve calcium score (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.