Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430806
Recruitment Status : Unknown
Verified September 2011 by moti haim, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 8, 2011
Last Update Posted : September 8, 2011
Information provided by (Responsible Party):
moti haim, Rabin Medical Center

Brief Summary:

Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone.

Several case reports have shown promising results with Dronedarone for this patient population.

Condition or disease Intervention/treatment Phase
ICD ICD SHOCKS DRONEDARONE Drug: Dronedarone arm Drug: Dronedarone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation
Study Start Date : October 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Dronedarone
U.S. FDA Resources

Arm Intervention/treatment
Dronedrone Arm Drug: Dronedarone arm
PO Dronedarone 400 mg BID
Drug: Dronedarone
Dronedarone PO 400 MG BID

Primary Outcome Measures :
  1. Number of ICD shocks due to VT in the 6 months period after starting Dronedarone [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:


Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center Identifier: NCT01430806     History of Changes
Other Study ID Numbers: 6402
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors