Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study
Open accessAbstract
Background Currently available antiarrhythmic agents for the treatment of atrial fibrillation (AF) have important limitations, leaving an unmet need for safe and effective therapy. Ranolazine is an approved antianginal agent with a favorable safety profile and electrophysiologic properties suggesting a potential role in the treatment of AF.Objective The purpose of this study was to assess the safety and efficacy of ranolazine in the prevention of AF recurrence after successful electrical cardioversion and to ascertain the most appropriate dose of this agent.Methods This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent AF (7 days to 6 months) 2 hours after successful electrical cardioversion to placebo, or ranolazine 375 mg, 500 mg, or 750 mg bid. Patients were monitored daily by transtelephonic ECG. The primary end-point was the time to first AF recurrence.Results Of 241 patients randomized, 238 took at least 1 drug dose. Ranolazine proved to be safe and tolerable. No dose of the drug significantly prolonged time to AF recurrence. AF recurred in 56.4%, 56.9%, 41.7%, and 39.7% of patients in the placebo, ranolazine 375 mg, ranolazine 500 mg, and ranolazine 750 mg groups, respectively. The reduction in overall AF recurrence in the combined 500-mg and 750-mg groups was of borderline significance compared to the placebo group (P = .053) and significant compared to 375-mg group (P = .035).Conclusion No dose of ranolazine significantly prolonged time to AF recurrence. However, the 500-mg and 750 mg-groups combined reduced AF recurrences, suggesting a possible role for this agent in the treatment of AF.
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- Authors
- De Ferrari, G. M., Maier, L. S., Mont, L., Schwartz, P. J., Simonis, G., Leschke, M., Gronda, E., Boriani, G., Darius, H., Guillamón Torán, L., Savelieva, I., Dusi, V., Marchionni, N., Quintana Rendón, M., Schumacher, K., Tonini, G., Melani, L., Giannelli, S., Alberto Maggi, C., & John Camm, A.
- Affiliations
- University Hospital Regensburg (DE)
- IRCCS Istituto Auxologico Italiano (IT)
- Klinikum Esslingen (DE)
- MultiMedica (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Vivantes Klinikum (DE)
- St George's, University of London (GB)
- University of Pavia (IT)
- Azienda Ospedaliero-Universitaria Careggi (IT)
- Menarini Group (Germany) (DE)
- Menarini Group (Italy) (IT)
- ORCID
- Venue
- Heart Rhythm
- Publisher
- Elsevier BV
- Published
- 2015-05
- Volume
- 12
- Issue
- 5
- Pages
- 872-878
- ISSN
- 1547-5271 (ISSN-L)
- OpenAlex
- W1984662555
- Cited by
- 87
- References
- 31
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 5 · 2023: 2 · 2022: 1 · 2021: 6 · 2020: 8 · 2019: 3 · 2018: 9 · 2017: 9 · 2016: 22 · 2015: 10
- FWCI
- 12.12
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- Heart Rhythm (publishedVersion)
- PubMed (publishedVersion)
- University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
- Florence Research (University of Florence) (submittedVersion)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
- Keywords
- ranolazine, atrial fibrillation, electrical cardioversion, atrial fibrillation recurrence, antiarrhythmic drugs, dose-ranging, persistent atrial fibrillation, drug safety and tolerability
- MeSH terms
- Ranolazine, Aged, Atrial Fibrillation, Cardiovascular Agents, Dose-Response Relationship, Drug, Double-Blind Method, Electric Countershock, Female, Humans, Male, Middle Aged, Electrocardiography, Ambulatory, Treatment Outcome, Drug Monitoring, Secondary Prevention
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