Comparing Antazoline and Propafenone for Atrial Fibrillation Treatment

Clinical Efficacy and Safety of Antazoline in Comparison to Propafenone in Conversion of Paroxysmal Atrial Fibrillation to Sinus Rhythm - a Single Center, Randomized, Double-blinded Study (the AnProAF Study).

This study is testing if a new medication called antazoline can quickly and safely help people with recent atrial fibrillation get back to a normal heart rhythm, compared to the standard treatment, propafenone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Centre of Postgraduate Medical Education (other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT05720572 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of antazoline versus propafenone in converting paroxysmal non-valvular atrial fibrillation to sinus rhythm in patients without heart failure. It is a randomized, double-blind, non-inferiority trial that seeks to determine if antazoline, an antihistaminic agent with antiarrhythmic properties, can provide a rapid and effective alternative to propafenone. The study will enroll participants aged 18 to 90 years who have experienced atrial fibrillation lasting less than 48 hours. The trial will assess the outcomes of pharmacological cardioversion using these two medications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 years with paroxysmal non-valvular atrial fibrillation lasting less than 48 hours.

Not a fit: Patients with significant valvular disease, heart failure, or those who are allergic to antazoline or propafenone may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients experiencing atrial fibrillation.

How similar studies have performed: Other studies have explored the use of antiarrhythmic drugs for atrial fibrillation, but the specific comparison of antazoline to propafenone is novel.

Eligibility criteria

Inclusion Criteria:

* Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted at the Department of Heart Disease, Warsaw, Poland
* Age 18 to 90years
* AF lasting \< 48 hours
* Stable cardio-pulmonary state on enrollment
* In case of unclear history of heart failure or suspicion of left ventricle damage echocardiographyis indicated prior to enrollment

Exclusion Criteria:

* Lack of written informed consent
* Allergy to antazoline or propafenone
* Intolerance of anatzoline or propafenone
* AF related to significant valvular disease
* Clinically significant heart failure or ejection fraction \<50%
* Systolic blood pressure (BP) \<100 mmHg
* History of significant bradyarrhythmia not treatedwith permanent pacemaker
* Resting ventricular rate of \< 80 bpm without pacemaker backup
* Heart rate \> 140 bpm
* Tachycardia \>160'
* Advanced liver or kidney failure
* Acute coronary syndrome, coronary artery by-passgraft, stroke or transient ischemic attack within 30 days before enrollment
* Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway
* Signs and symptoms of ischemia related to AF
* An investigational drug used within 30 days before enrollment
* Advanced liver or kidney failure
* QT prolongation over 440 ms or QTc (Bazett's formula) over the population norm
* Pregnancy or breast feeding
* Background therapy of any oral AADs.

Where this trial is running

Warsaw

• Postgraduate Medical School — Warsaw, Poland (RECRUITING)

Study contacts

• Principal investigator: Jarosław JK Karwowski, PhD — Centre of Postgraduate Medical Education
• Study coordinator: Jarosław JK Karwowski, PhD

Conditions: Atrial Fibrillation, Antazoline, Antiarrhythmic drugs, Pharmacological cardioversion, Atrial fibrillation, Randomized controlled trial