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The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden measured with a pacemaker device
The aim of the study is to find out the effect of a direct renin inhibitor, aliskiren, in reduction of AF with patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.
Hypothesis is that there is a possibility to reduce atrial remodeling due to AF and also to enhance atrial reverse remodeling with aliskiren. The effect of aliskiren to total AF burden will be evaluated from the pacemaker's memory storage.
The main purpose of the study is to find new and safe drug treatments targeting to reduce AF recurrences and related complications in pacemaker patients. Also the aim is to evaluate the feasibility of a modern and highly sophisticated pacemaker system in the evaluation of drug treatment with AF reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aliskiren | Active Comparator | Aliskiren 300 once a day (q.d) |
|
| placebo | Placebo Comparator | Placebo once a day (q.d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| burden of atrial fibrillation | From the start of the study to the end of the study; 0 - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of AF episodes | From the start of the study to the end of the study; 0 - 12 months | |
| number of persistent AF episodes lasting more than 48 hours | From the start of the study to the end of the study; 0 - 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mika Lehto, MD, PhD | Contact | +358505447487 | mika.lehto@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Recruiting | Helsinki | 00029 | Finland |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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| the length of the paced P-wave measured by high resolution ECG (SAECG) | after each 6-month period |
| D013568 |
| Pathological Conditions, Signs and Symptoms |