Clinical Trial Registration: Trial conducted between 1996 and 1998 and not included in a clinical trials registration database.
Dronedarone is a novel multichannel blocker with antiadrenergic and vasodilatory properties. The aim of this study was to investigate the effects of dronedarone on functional capacity in patients with severe left ventricular (LV) dysfunction and compensated stable heart failure (HF).
This was a multicentre, double-blind, randomized, placebo-controlled, dose-escalating study. Patients in sinus rhythm with impaired LV function (LV ejection fraction [LVEF] ≤ 30%) and compensated HF (New York Heart Association [NYHA] class I–II), who would continue to receive cardiovascular treatment (excluding antiarrhythmic agents), were eligible. A total of 124 patients were randomized to receive dronedarone (400 mg or 800 mg once daily or 600 mg twice daily) or placebo for 30 days. The primary objective was assessment of the effects of dronedarone on functional capacity, using the 6 min walk test. Secondary objectives included the effects of dronedarone on LVEF, cardiothoracic ratio, NYHA status, and Holter parameters.
A total of 111 patients completed the study. There were no significant differences between dronedarone and placebo with respect to walking distance and LVEF. The cardiothoracic ratio was similar in all treatment groups throughout the study, and the NYHA status did not change in the majority of patients. Dronedarone was well tolerated and, as expected, decreased heart rate. No new arrhythmic events or torsades de pointes were reported.
Short-term treatment with dronedarone did not affect exercise capacity and did not decrease LVEF in patients with severe LV dysfunction and compensated HF.
Fuster V, Rydén LE, Cannom DS, et al. American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006;8:651–745. PubMedCrossRef
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22:983–8. PubMed
Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham heart study. Circulation. 1998;98:946–52. PubMed
Zareba KM. Dronedarone: a new antiarrhythmic agent. Drugs Today (Barc). 2006;42:75–86. CrossRef
Davy JM, Herold M, Hoglund C, et al. ERATO Study Investigators. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008;156:527–9. PubMedCrossRef
Davy JM, Herold M, Hoglund C, Radzik D, Timmermans AJM. Effect of dronedarone on exercise in patients with permanent atrial fibrillation. Eur Heart J. 2006;1:885.
MULTAQ (dronedarone) tablets [prescribing information]. http://products.sanofi-aventis.us/multaq/multaq.pdf. Accessed 8 Jan 2010.
World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Hong Kong. 1989.
Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed). 1986;292:653–5. CrossRef
Rocchetti M, Bertrand JP, Nisato D. Cellular electrophysiological study of dronedarone, a new amiodarone-like agent, in guinea pig sinoatrial node. Naunyn-Schmiedebergs Arch Pharmacol. 1998;358:R617.
- Effect of Dronedarone on Exercise Capacity and Cardiac Function in Patients With Severe Left Ventricular Dysfunction and Compensated Stable Heart Failure
T. Barry Levine
Jalal K. Ghali
- Springer US
Neu im Fachgebiet Kardiologie
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