Could a common heart drug be safer for patients with two heart conditions?
NCT ID NCT07405671
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 988 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
14 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AZ Rivierenland
NOT_YET_RECRUITINGRumst, 2840, Belgium
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AZ ST-JAN Brugge A.V.
NOT_YET_RECRUITINGBruges, 8000, Belgium
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AZ St.-Elisabeth Herentals VZW
NOT_YET_RECRUITINGHerentals, 2200, Belgium
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AZ Turnhout
NOT_YET_RECRUITINGTurnhout, 2300, Belgium
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AZorg
NOT_YET_RECRUITINGAalst, 9300, Belgium
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Algemeen Ziekenhuis Delta
NOT_YET_RECRUITINGRoeselare, 8800, Belgium
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Algemeen Ziekenhuis Groeninge
NOT_YET_RECRUITINGKortrijk, 8500, Belgium
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Az Maria Middelares Gent
NOT_YET_RECRUITINGGhent, 9000, Belgium
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Imelda
NOT_YET_RECRUITINGBonheiden, 2820, Belgium
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Jan Yperman Ziekenhuis
NOT_YET_RECRUITINGIeper, 8900, Belgium
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Universitair Ziekenhuis Antwerpen
NOT_YET_RECRUITINGEdegem, 2650, Belgium
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Vitaz
NOT_YET_RECRUITINGSint-Niklaas, 9100, Belgium
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Ziekenhuis Oost Limburg
NOT_YET_RECRUITINGGenk, 3600, Belgium
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Other studies related to the condition(s) this trial covers.
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