Atrial Fibrillation (AF)Phase 4ReCAST AFNCT07405671
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
A Phase 4 study testing flecainide and Sotalol or Amiodarone in people with Atrial Fibrillation (AF) and Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 14 sites in Belgium.
Trial summary
The goal of this clinical trial is to learn whether the antiarrhythmic drug flecainide can be used as safely as standard rhythm-control drugs in people with atrial fibrillation (AF) and stable coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Coronary Artery Disease
- What is being tested?
- flecainide and Sotalol or Amiodarone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 988 participants
- Where
- 14 sitesBelgium
- Study dates
- Sep 2026to Dec 2029
- Phase
- Phase 4
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form
- Non-permanent atrial fibrillation or ectopic atrial tachycardia with rhythm control strategy, documented on any modality in the 1 year preceding the consent date
- Stable coronary artery disease without argument, defined as:
- Prior percutaneous coronary intervention; OR
- Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR
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- Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR
- 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.
- LVEF ≥ 45% documented on any imaging modality*
Who cannot join
- LVEF < 45%
- NYHA class III or IV congestive heart failure
- Active treatment with amiodarone
- History of intolerance of flecainide or both sotalol and amiodarone
- Clinically significant uncorrected hypokalemia or hypomagnesemia before initiation of trial treatment.
- Evidence or history of thyroid dysfunction contraindicating amiodarone use, where amiodarone would be prescribed as standard of care treatment.
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- Hypersensitivity to the active substances or any excipients.
- Unstable angina or inducible ischemia on exercise stress testing, myocardial perfusion imaging, stress cardiac MRI, or fractional flow reserve performed for clinical indications
- Baseline QRS duration ≥ 120 ms, unless a functioning pacemaker is present
- Baseline corrected QT interval (Fridericia) ≥ 500 ms
- Pre-existing advanced AV block (second-, or third-degree)
- Pre-existing sick sinus syndrome or sinus bradycardia <50 bpm
- Known channelopathy
- Contra-indication to AV-slowing agents, including beta-blockers, diltiazem or verapamil
- Atrial fibrillation due to reversible cause
- Active intracardiac thrombus
- Acute coronary syndrome during the 3-month period preceding the consent date
- 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
- Moderate or severe congenital heart disease as per 2020 ESC guidelines
- Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- Significant chronic kidney disease (eGFR <40 mL/min)
- Life expectancy less than 1 year
- 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
- 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.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bert Vandenberk, MD PhD MSc contact
14 sites in 1 country
Belgium14 sites, 14 recruiting
- Recruiting
AZorg
Aalst, 9300
Tom De Potter, +3253724180, tom.de.potter@azorg.be
- Not yet recruiting
Imelda
Bonheiden, 2820
Thomas Rosseel, +3215506191, thomas.1.rosseel@uzleuven.be
- Not yet recruiting
AZ ST-JAN Brugge A.V.
Bruges, 8000
Mattias Duytschaever, +3250452670, mattias.duytschaever@azsintjan.be
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Hein Heidbuchel, +3238213538, hein.heidbuchel@uza.be
- Not yet recruiting
Ziekenhuis Oost Limburg
Genk, 3600
Dieter Nuyens, +3289804226, dieter.nuyens@zol.be
- Not yet recruiting
Az Maria Middelares Gent
Ghent, 9000
Martijn Rogiers, +3292468600, martijn.rogiers@azmmsj.be
- Not yet recruiting
AZ St.-Elisabeth Herentals VZW
Herentals, 2200
Annemie Voet, +3214246111, annemie.voet@azherentals.be
- Not yet recruiting
Jan Yperman Ziekenhuis
Ieper, 8900
Anouar Belkacemi, +31497080988, anouar.belkacemi@gmail.com
- Not yet recruiting
Algemeen Ziekenhuis Groeninge
Kortrijk, 8500
Tim Boussy, +3256633100, tim.boussy@azgroeninge.be
- Recruiting
UZ Leuven
Leuven, 3000
Joris Ector, +3216341487, Joris.Ector@uzleuven.be
- Not yet recruiting
Algemeen Ziekenhuis Delta
Roeselare, 8800
Wim Anné, +3251237226, wim.anne@azdelta.be
- Not yet recruiting
AZ Rivierenland
Rumst, 2840
Maxime Tijskens, +3238809011, Maxime.Tijskens@azr.be
- Not yet recruiting
Vitaz
Sint-Niklaas, 9100
Siegmund Keuleers, +3237608553, siegmund.keuleers@vitaz.be
- Recruiting
AZ Turnhout
Turnhout, 2300
Anton Verrijcken, +3214406461, anton.verrijcken@azturnhout.be
About this study
Official title: Randomized Evaluation of fleCAinide Safety Versus STandard of Care in Patients With Coronary Artery Disease and Atrial Fibrillation
The goal of this clinical trial is to learn whether the antiarrhythmic drug flecainide can be used as safely as standard rhythm-control drugs in people with atrial fibrillation (AF) and stable coronary artery disease (CAD). The study includes adults aged 18 years and older who have AF and known but stable coronary artery disease.
The main questions this study aims to answer are:
Read more
- Is treatment with flecainide as safe as standard rhythm-control drugs (sotalol or amiodarone) in this patient group?
- Does flecainide lead to similar or fewer serious side effects, hospitalisations, or deaths compared with standard treatment?
Researchers will compare patients treated with flecainide to patients treated with standard rhythm-control therapy (sotalol or amiodarone) to see whether flecainide is not worse in terms of safety outcomes.
Participants will:
- Be randomly assigned to receive either flecainide or standard rhythm-control medication
- Take the assigned medication as part of routine clinical care
- Attend regular follow-up visits at the hospital and have additional follow-up by telephone
- Undergo routine heart tests such as electrocardiograms and echocardiography
- Complete questionnaires about symptoms, quality of life, and daily functioning
This study follows patients for at least one year and collects information on safety, heart rhythm outcomes, quality of life, and healthcare use.
- Conditions
- Atrial Fibrillation (AF), Coronary Artery Disease
- Being tested
- flecainide, Sotalol or Amiodarone
- Keywords
- atrial fibrillation, rhythm control, stable coronary artery disease, flecainide, sotalol, amiodarone
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flecainideDrug
Flecainide, a class Ic anti-arrhythmic drug Recommended starting dose of 100 to 150 mg per day per os, either spread in 2 equal doses BID or in 1 dose OD with controlled release formulation.
Flecainide will always be combined with an AV nodal blocker (beta-blocker or diltiazem/verapamil).
Sotalol or AmiodaroneDrug
Class III anti-arrhythmic drug: Sotalol or amiodarone as per physician preference.
Recommended starting doses:
- Sotalol: 80 mg BID per os, with a dose adjustment to once daily if the eGFR is between 40 and 60 mL/min.
- Amiodarone: loading dose of 600 mg daily per os in divided doses for 1 week, followed by 400 mg daily per os in divided doses for 1 week, and subsequently 200 mg per os once daily.
| Study group | Role | What they receive |
|---|---|---|
| Flecainide | Experimental | Flecainide, a class Ic anti-arrhythmic drug. Receives: Drug: flecainide |
| Sotalol or Amiodarone | Active comparator | Class III anti-arrhythmic drug: sotalol or amiodarone as per physician preference. Receives: Drug: Sotalol or Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite safety outcome
The primary outcome measure is a composite safety outcome including all-cause mortality, severe adverse events leading to drug discontinuation, and unscheduled hospitalisation for heart failure or acute coronary syndrome. Each of these individual components is assessed as secondary outcome.
Measured: 1 year
Secondary outcomes (17)
All-cause mortality
Death from any cause
Measured: 1 year
Severe adverse events leading to drug discontinuation
Any severe AE leading to intervention discontinuation, including bradyarrhythmias, ventricular arrhythmias, atrial flutter with 1:1 conduction, QT/QRS prolongation, serious extra-cardiac adverse events
Measured: 1 year
Unscheduled hospitalisation for heart failure or acute coronary syndrome
Unscheduled hospitalisation for heart failure or acute coronary syndrome
Measured: 1 year
AF recurrence
Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF)
Measured: 1 year
Major adverse cardiovascular events
Composite of cardiovascular death, myocardial infarction, stroke
Measured: 1 year
Catheter ablation
Incidence of catheter ablation for AF during follow-up
Measured: 1 year
Cardiovascular hospitalisation duration
Total number of days of cardiovascular hospitalisation
Measured: 1 year
Treatment-related adverse events
All serious adverse events and adverse events:
- Frequency and severity of all treatment-emergent adverse events
- Proportion of participants experiencing at least one AE/SAE.
- Specific drug-related adverse events (e.g., QT prolongation, proarrhythmia, bradycardia, hypotension, fatigue, gastrointestinal disturbances).
Measured: 1 year
Cardiac function - LVEF
Changes in cardiac function assessed by left ventricular ejection fraction expressed in percentages (%) from baseline measured by echocardiography
Measured: 3 months
NT-proBNP
Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) at 3 months from baseline
Measured: 3 months
QTc
Change in QTc interval (ms) and QRS duration (ms) from baseline
Measured: 1 year
Healthcare resource utilization
Total within-trial healthcare resource utilization expressed in Euro (€)
Measured: 1 year
Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
Change in patient reported outcomes assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. The AFEQT questionnaire is a 20-item, disease-specific, patient-reported outcome measure ranging from 0 to 100 with a higher value corresponding to a better quality of life.
Measured: 1 year
EuroQoL-5 dimension health utility index (EQ-5D-5L)
Change in patient-reported outcome as assessed by the EuroQoL-5 dimension health utility index (EQ-5D-5L) questionnaire. The EQ-5D-5L measures health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on five severity levels (1=no problem to 5=extreme problem). Results are interpreted via a 5-digit health state profile (e.g., 11211), a calculated utility index (ranging from <0 to 1, where 1=full health), and a 0-100 Visual Analog Scale (VAS). A higher score corresponds to a better quality of life.
Measured: 1 year
Short Form-12 (SF-12) health survey
Change in patient-reported outcome as assessed by the Short Form-12 (SF-12) health survey. The Short Form-12 (SF-12) health survey is interpreted by calculating two main, norm-based scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-where a score of 50 represents the average for the general population. Scores above 50 indicate better-than-average health-related quality of life, while scores below 50 indicate below-average health.
Measured: 1 year
EHRA symptom score
Change in patient-reported outcome as assessed by the European Heart Rhythm Association (EHRA) symptom score. The EHRA symptom score is a standardized, four-level classification system used to quantify the severity of symptoms in patients with atrial fibrillation based on how they impact daily activities.
EHRA Symptom Score Classification (I-IV):
EHRA I (Asymptomatic): No symptoms are experienced. EHRA II (Mild Symptoms): Normal daily activity is not affected. EHRA III (Severe Symptoms): Normal daily activity is affected. EHRA IV (Disabling Symptoms): Normal daily activity is discontinued.
Measured: 1 year
Work Productivity and Activity Impairment (WPAI) questionnaire
Change in patient-reported outcome as assessed by the Work Productivity and Activity Impairment (WPAI) questionnaire. The WPAI questionnaire is interpreted by calculating four key impairment percentages over the past 7 days, with higher scores (0-100%) indicating greater impairment and lower productivity. It measures absenteeism (time missed), presenteeism (impairment while working), overall work loss, and daily activity impairment, using a 0-10 scale for productivity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, pragmatic, 2-arm, parallel group, open-label, individually randomised controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 988 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405671
- Sponsor's protocol ID
- S69367
- Other IDs
- 2025-525121-13, 2025
- Acronym
- ReCAST AF
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes