Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

September 7, 2011 updated by: moti haim, Rabin Medical Center

Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dronedrone Arm
Drug: Dronedarone arm
PO Dronedarone 400 mg BID
Drug: Dronedarone
Dronedarone PO 400 MG BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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