Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
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ClinicalTrials.gov Identifier: NCT00225667 |
Recruitment Status : Unknown
Verified November 2005 by Connolly, Stuart, M.D..
Recruitment status was: Not yet recruiting
First Posted : September 26, 2005
Last Update Posted : November 23, 2005
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | September 12, 2005 | |||||||||||||||
First Posted Date ICMJE | September 26, 2005 | |||||||||||||||
Last Update Posted Date | November 23, 2005 | |||||||||||||||
Study Start Date ICMJE | December 2005 | |||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||
Current Primary Outcome Measures ICMJE |
Time to recurrent AHRE ( 220/min for > 2 minutes) | |||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers | |||||||||||||||
Official Title ICMJE | Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation | |||||||||||||||
Brief Summary | The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker. | |||||||||||||||
Detailed Description | Patients with permanent pacemakers have a high risk of atrial fibrillation (AF), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (AHRE). AHRE are felt to be a precursor to AF, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of AF. Evaluating this process in human AF has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. However, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document AHRE, which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF. In addition, this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling. Comparison: Irbesartan compared to placebo. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Irbesartan | |||||||||||||||
Study Arms ICMJE | Not Provided | |||||||||||||||
Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Unknown status | |||||||||||||||
Enrollment ICMJE |
200 | |||||||||||||||
Original Enrollment ICMJE | Same as current | |||||||||||||||
Study Completion Date ICMJE | July 2007 | |||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Canada | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00225667 | |||||||||||||||
Other Study ID Numbers ICMJE | 099104 CTA-099104 |
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Has Data Monitoring Committee | Not Provided | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | Not Provided | |||||||||||||||
Study Sponsor ICMJE | Connolly, Stuart, M.D. | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Connolly, Stuart, M.D. | |||||||||||||||
Verification Date | November 2005 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |