Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a common gout drug save hearts? colchicine trial targets valve disease

NCT ID NCT05162742

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether colchicine, an anti-inflammatory drug, can slow the progression of aortic valve stenosis—a narrowing of the heart's aortic valve that currently has no drug treatment. The study enrolls 150 people with moderate, symptom-free valve disease. Participants receive either colchicine or a placebo for up to 2 years, and researchers track changes in valve calcium buildup and other measures. If successful, colchicine could become the first medical therapy for this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
colchicine
What this could lead to
If it works, this could be the first drug to slow aortic valve stenosis, potentially delaying or avoiding the need for valve replacement surgery.
What could go wrong
This is a relatively small phase 3 trial (150 people) testing a drug already used for other conditions. The effect may be modest or not significant, and colchicine can cause side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve calcification are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve calcification Aortic Valve Disease aortic valve disorder aortic valve stenosis Aortic Valve, Calcification of calcinosis cardiovascular disorder Inflammation inflammatory disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve calcification Aortic valve disease Aortic valve stenosis Calcification Cardiovascular diseases Inflammation

Contacts and locations

Locations

  • Radboudumc

    Nijmegen, The Netherlands, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.