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Could a common heart drug be safer for patients with two heart conditions?

NCT ID NCT07405671

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study compares the safety of the drug flecainide against standard treatments (sotalol or amiodarone) in about 988 adults with atrial fibrillation and stable coronary artery disease. Participants will be randomly assigned to one treatment and followed for at least a year to track serious side effects, hospitalizations, and deaths. The goal is to see if flecainide is a safe option for managing heart rhythm in this group.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 988 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

18 years and older

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 Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form 3. Non-permanent atrial fibrillation or ectopic atrial tachycardia with rhythm control strategy, documented on any modality in the 1 year preceding the consent date 4. Stable coronary artery disease without argument, defined as: 1. Prior percutaneous coronary intervention; OR 2. Prior revascularised ACS or coronary artery bypass surgery \> 3 months at enrolment; OR 3. Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR 4. Coronary CT scan showing coronary stenosis CAD-RADS stage ≥ 3 on, including CAD-RADS stages 4 and 5 in the absence of ischemia on exercise testing, myocardial perfusion imaging (MIBI), stress cardiac MRI, or fractional flow reserve. 5. LVEF ≥ 45% documented on any imaging modality\* Exclusion Criteria: 1. LVEF \< 45% 2. NYHA class III or IV congestive heart failure 3. Active treatment with amiodarone 4. History of intolerance of flecainide or both sotalol and amiodarone 5. Clinically significant uncorrected hypokalemia or hypomagnesemia before initiation of trial treatment. 6. Evidence or history of thyroid dysfunction contraindicating amiodarone use, where amiodarone would be prescribed as standard of care treatment. 7. Hypersensitivity to the active substances or any excipients. 8. Unstable angina or inducible ischemia on exercise stress testing, myocardial perfusion imaging, stress cardiac MRI, or fractional flow reserve performed for clinical indications 9. Baseline QRS duration ≥ 120 ms, unless a functioning pacemaker is present 10. Baseline corrected QT interval (Fridericia) ≥ 500 ms 11 Pre-existing advanced AV block (second-, or third-degree) 12\. Pre-existing sick sinus syndrome or sinus bradycardia \<50 bpm 13. Known channelopathy 14. Contra-indication to AV-slowing agents, including beta-blockers, diltiazem or verapamil 15. Atrial fibrillation due to reversible cause 16. Active intracardiac thrombus 17. Acute coronary syndrome during the 3-month period preceding the consent date 18. Cardiac surgery, including coronary artery bypass surgery, during the 3-month period preceding the consent date or planned at a future date at the time of consent 19. Moderate or severe congenital heart disease as per 2020 ESC guidelines 20. Hypertrophic cardiomyopathy (septal or posterior wall thickness \>1.5 cm) 21. Significant chronic kidney disease (eGFR \<40 mL/min) 22. Life expectancy less than 1 year 23. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 24. Inability to provide written informed consent, including decision-making incapacity due to cognitive impairment or other medical or psychiatric conditions that preclude adequate understanding of the study and its procedures. 25\. Participation in an interventional Trial with an investigational medicinal product (IMP) or device

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Rivierenland

    NOT_YET_RECRUITING

    Rumst, 2840, Belgium

  • AZ ST-JAN Brugge A.V.

    NOT_YET_RECRUITING

    Bruges, 8000, Belgium

  • AZ St.-Elisabeth Herentals VZW

    NOT_YET_RECRUITING

    Herentals, 2200, Belgium

  • AZ Turnhout

    NOT_YET_RECRUITING

    Turnhout, 2300, Belgium

  • AZorg

    NOT_YET_RECRUITING

    Aalst, 9300, Belgium

  • Algemeen Ziekenhuis Delta

    NOT_YET_RECRUITING

    Roeselare, 8800, Belgium

  • Algemeen Ziekenhuis Groeninge

    NOT_YET_RECRUITING

    Kortrijk, 8500, Belgium

  • Az Maria Middelares Gent

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • Imelda

    NOT_YET_RECRUITING

    Bonheiden, 2820, Belgium

  • Jan Yperman Ziekenhuis

    NOT_YET_RECRUITING

    Ieper, 8900, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen

    NOT_YET_RECRUITING

    Edegem, 2650, Belgium

  • Vitaz

    NOT_YET_RECRUITING

    Sint-Niklaas, 9100, Belgium

  • Ziekenhuis Oost Limburg

    NOT_YET_RECRUITING

    Genk, 3600, Belgium

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