- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225667
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Stuart J. Connolly, MD
- Phone Number: 44563 905-527-4322
- Email: connostu@hhsc.ca
Study Contact Backup
- Name: Jeffrey S. Healey, MD
- Phone Number: 44789 905-527-4322
- Email: healeyj@hhsc.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Population Health Research Institute of McMaster University
-
Contact:
- Ellison J. Themeles, MSc.
- Phone Number: 44713 905-527-4322
- Email: themelese@ccc.mcmaster.ca
-
Principal Investigator:
- Stuart J. Connolly, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sinus Node Dysfunction (with or without AV conduction disturbance)
- Permanent, atrial or dual-chamber pacemaker implanted > 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
- History of at least 6 AHRE in the last 6 months (rate > 220/min, duration of > 2 minutes
- History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP > 130/85 (measurements done at least one week apart)
Exclusion Criteria:
- Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
- Documented Cr >200 umol/L and K+ >5.2 mmol/L in the previous 3 months
- Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
- LV ejection fraction known to be < 40 %
- Moderate or severe mitral regurgitation (3+, 4 +)
- Mitral stenosis of more than mild severity
- Aortic stenosis with mean gradient of > 25 mmHg
- Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
- Unipolar atrial lead
- Previous AV node ablation
- P-wave amplitude less than 1.5 mV
- Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
- Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to recurrent AHRE ( 220/min for > 2 minutes)
|
Secondary Outcome Measures
Outcome Measure |
---|
- Frequency of AHRE's (> 220/min for > 2 minutes) Evaluated at randomization, month 1 and 6.
|
- Development of sustained AF (>30 minutes), documented
|
by ECG, holter, rhythm strip or pacemaker electrograms
|
- Electrical Remodeling (AERP,SNRT,paced/sensed p-wave
|
duration). Evaluated at randomization, months 1 and 6.
|
- Markers of Inflammation (Plasma CRP,TNF-alpha, D-Dimer,
|
IL-6, Pro-collagen-III products, BNP,MPO,hsP). Blood collection at randomization and month 6.
|
- Structural Remodeling (left atrial volume, left
|
ventricular mass, left ventricular diastolic function. Evaluated at randomization and month 6.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stuart J. Connolly, MD, McMaster University
- Principal Investigator: Jeffrey S Healey, MD, McMaster University
- Principal Investigator: Carlos A Morillo, MD, McMaster University
- Principal Investigator: Stefan H Hohnloser, MD, J.W. Goethe University, Frankfurt Germany
- Principal Investigator: Carsten W Israel, MD, J.W. Goethe University, Frankfurt Germany
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pathological Conditions, Anatomical
- Hypertension
- Atrial Fibrillation
- Arrhythmias, Cardiac
- Atrial Remodeling
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Irbesartan
Other Study ID Numbers
- 099104
- CTA-099104
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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Recruiting
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Irbesartan
-
The Affiliated Hospital of Qingdao UniversityCompleted
-
SanofiCompleted
-
Bristol-Myers SquibbSanofiCompletedHypertensionUnited States, Belgium, Canada, Germany, Russian Federation, France, Israel, Netherlands
-
SanofiBristol-Myers SquibbCompletedHypertensionUnited States
-
Steno Diabetes Center CopenhagenCompletedType 2 Diabetes | MicroalbuminuriaDenmark
-
Steno Diabetes Center CopenhagenBristol-Myers Squibb; Sanofi-SynthelaboCompletedHypertension | Type 2 Diabetes | Microalbuminuria
-
Zhi-Hong Liu, M.D.Terminated
-
University of Southern DenmarkBristol-Myers SquibbCompleted
-
Travere Therapeutics, Inc.Active, not recruitingImmunoglobulin A NephropathyUnited States, Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Hong Kong, Italy, Korea, Republic of, Lithuania, New Zealand, Poland, Portugal, Spain, Taiwan, United Kingdom
-
Jiangsu Famous Medical Technology Co., Ltd.Unknown