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Old gout drug may keep heart in rhythm after valve surgery

NCT ID NCT04870424

Prevention Sponsor: Insel Gruppe AG, University Hospital Bern 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether colchicine, an anti-inflammatory drug used for gout, can prevent new-onset atrial fibrillation and the need for a permanent pacemaker in people undergoing transcatheter aortic valve replacement (TAVI). About 120 older adults with severe aortic stenosis were randomly assigned to receive colchicine or a placebo for 30 days after the procedure. The goal was to see if colchicine's anti-inflammatory effects could reduce common post-TAVI heart rhythm complications.

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 offer a simple, inexpensive way to prevent common heart rhythm problems after valve replacement, reducing the need for a permanent pacemaker.
What could go wrong
This is a small, completed Phase 3 trial with 120 participants, so results may not apply to everyone. Colchicine can cause side effects like stomach upset, and its benefit here is not yet proven.

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

120 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2025

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

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Criteria: 1. Age ≥ 65 years 2. Symptomatic severe aortic stenosis defined by an aortic valve area (AVA) ≤1.0 cm2 or an AVA indexed to body surface area \<0.6cm2/m2 3. Selected to undergo transfemoral TAVI based on heart team decision Exclusion Criteria: 1. Life expectancy \<1 year irrespective of valvular heart disease 2. Kidney disease with a creatinine clearance ≤30 ml/min 3. Known severe liver disease 4. Known neuromuscular disease 5. Clinically significant anaemia with haemoglobin \<80g/L 6. Known inflammatory bowel disease or chronic diarrhea 7. Known ongoing bacterial infection 8. Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 9. Current treatment with colchicine, steroids or biologicals for any indication 10. Concomitant intake of Cyclosporine, Amiodarone, Clarithromycin, Erythromycin, Omeprazole, Verapamil or other strong inhibitors of CYP3A4 or P-Glycoprotein 11. Concomitant intake of Carbamazepin, Phenobarbital, Phenytoin, Rifampicin or other strong inductors of CYP3A4 and P-Glycoprotein 12. Permanent pacemaker or implantable cardioverter defibrillator 13. History of atrial fibrillation 14. Absence of sinus rhythm on hospital admission 15. Planned non-cardiac surgery within 30 days 16. Known intolerance to colchicine 17. Inability to provide written informed consent 18. Known or suspected non-compliance, drug or alcohol abuse 19. Participation in another clinical trial with an active intervention 20. Any other planned cardiac intervention performed in the 7 days before TAVI, concomitantly with TAVI or in the 30 days after TAVI except for percutaneous coronary interventions.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis colchicine poisoning atrial fibrillation prevention target third-degree atrioventricular block prevention target

As listed by the trial registrant

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

Atrial fibrillation new onset Colchicine Pacemaker Transcatheter aortic valve replacement

Contacts and locations

Locations

  • Inselspital, Bern University Hospital, Department of Cardiology

    Bern, 3010, Switzerland

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