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Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by moti haim, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430806
First Posted: September 8, 2011
Last Update Posted: September 8, 2011
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.
Information provided by (Responsible Party):
moti haim, Rabin Medical Center
  Purpose

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 Intervention
ICD ICD SHOCKS DRONEDARONE Drug: Dronedarone arm Drug: Dronedarone

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by moti haim, Rabin Medical Center:

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

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dronedrone Arm Drug: Dronedarone arm
PO Dronedarone 400 mg BID
Drug: Dronedarone
Dronedarone PO 400 MG BID

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:

  • CHF NYHA IV OR DECMPENSATED III
  • PERMANENT AF
  • LIVER DYSFUNCION
  • CR CLEARANCE <30
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: moti haim, Director, Electrophysiology Service,, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01430806     History of Changes
Other Study ID Numbers: 6402
First Submitted: September 7, 2011
First Posted: September 8, 2011
Last Update Posted: September 8, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Shock
Pathologic Processes
Amiodarone
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