Evaluating Refralon® for preventing recurrence of atrial fibrillation/flutter
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg (Pharmproekt JSC) for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form
This study is testing if Refralon® tablets can help prevent the return of atrial fibrillation or flutter in patients after their heart rhythm has been restored, comparing two doses to a placebo over six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06540352 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of Refralon® tablets in two different doses (1 or 2 tablets per day) compared to a placebo in patients with persistent atrial fibrillation/flutter after restoring sinus rhythm. The trial aims to determine the optimal dose of Refralon® and assess its pharmacokinetics over a period of 6 months. Patients will be monitored for recurrence of arrhythmia and overall safety during the treatment period.
Who should consider this trial
Good fit: Ideal candidates include patients with persistent atrial fibrillation/flutter lasting 7 days to 1 year and a left ventricular ejection fraction greater than 40%.
Not a fit: Patients with a history of myocardial infarction, structural heart disease, or those currently taking certain antiarrhythmic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of atrial fibrillation/flutter in patients, improving their quality of life.
How similar studies have performed: While this approach is novel in the context of Refralon®, similar studies evaluating antiarrhythmic drugs have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent form of AF/AFL lasting 7 days - 1 year (including patients who have previously undergone ineffective catheter or surgical ablation of AF or AFL and patients with a pacemaker or implanted cardioverter-defibrillator (ICD)); * Basic rhythm - AF and/or AFL according to the results of 12-lead ECG at randomization (Visit 2); * Left ventricular ejection fraction (LVEF) \>40% according to the Simpson method; Exclusion Criteria: * Intake of class IA, IC and class III antiarrhythmic drugs less than 7 days (for amiodarone less than 60 days) before the study drug intake; * History of myocardial infarction or other structural heart disease; * QT prolongation over 500 ms.
Where this trial is running
Moscow
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Organization — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Vadim Yu Kuznetsov, PhD
- Email: vykuznetsov@cardio.ru
- Phone: +74954146249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.