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| ID | Type | Description | Link |
|---|---|---|---|
| CTA-099104 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrent AHRE ( 220/min for > 2 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| - 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stuart J. Connolly, MD | Contact | 905-527-4322 | 44563 | connostu@hhsc.ca |
| Jeffrey S. Healey, MD | Contact | 905-527-4322 | 44789 | healeyj@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stuart J. Connolly, MD | McMaster University | Principal Investigator |
| Jeffrey S Healey, MD | McMaster University | Principal Investigator |
| Carlos A Morillo, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Population Health Research Institute of McMaster University | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| - 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. |
| 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 | Principal Investigator |
| D014652 | Vascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |