ICDNCT01430806
Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
A study testing Dronedarone arm and Dronedarone in people with ICD and ICD SHOCKS, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD, ICD SHOCKS, DRONEDARONE
- What is being tested?
- Dronedarone arm and Dronedarone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurernt ICD shocks depite other antiarrhythmic drug therapy
Who cannot join
- CHF NYHA IV OR DECMPENSATED III
- PERMANENT AF
- LIVER DYSFUNCION
- CR CLEARANCE <30
About this study
Official title: 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.
- Conditions
- ICD, ICD SHOCKS, DRONEDARONE
- Being tested
- Dronedarone arm, Dronedarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronedarone armDrug
PO Dronedarone 400 mg BID
DronedaroneDrug
Dronedarone PO 400 MG BID
| Study group | Role | What they receive |
|---|---|---|
| Dronedrone Arm | Other | Not described Receives: Drug: Dronedarone arm; Drug: Dronedarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, moti haim, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430806
- Sponsor's protocol ID
- 6402
- Status last verified
- Sep 2011
- First submitted
- 7 Sep 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation
- ClinicalTrials.gov ID
- NCT01430806
- Acronym / sponsor ID
- 6402
- Conditions
- ICD, ICD SHOCKS, DRONEDARONE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dronedrone Arm | Other | Drug: Dronedarone arm, Drug: Dronedarone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recurernt ICD shocks depite other antiarrhythmic drug therapy
Key exclusion criteria (4 listed)
- CHF NYHA IV OR DECMPENSATED III
- PERMANENT AF
- LIVER DYSFUNCION
- CR CLEARANCE <30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronedarone armPO Dronedarone 400 mg BID | Drug | Dronedrone Arm |
| DronedaroneDronedarone PO 400 MG BID | Drug | Dronedrone Arm |
Primary outcome
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dronedarone arm and Dronedarone in people with ICD and ICD SHOCKS, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2011.