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| ID | Type | Description | Link |
|---|---|---|---|
| Grant No 01GI0204 | Other Grant/Funding Number | BMBF |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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Hypothesis:
Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25% compared to standard medication without angiotensin II type 1 receptor.
A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery medication" (amiodarone) is allowed during follow-up.
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olmesartan | Experimental | Olmesartan tablet, 1 in the morning |
|
| Placebo | Placebo Comparator | Placebo tablets, 1 in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording) | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of a documented relapse of atrial fibrillation | 12 months follow up | |
| Time to first occurrence of a symptomatic documented episode of AF | 12 months follow up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Meinertz, MD | University Hospital Hamburg | Principal Investigator |
| Andreas Goette, MD | University Hospital Magdeburg | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24351885 | Derived | von Eisenhart Rothe AF, Goette A, Kirchhof P, Breithardt G, Limbourg T, Calvert M, Baumert J, Ladwig KH. Depression in paroxysmal and persistent atrial fibrillation patients: a cross-sectional comparison of patients enroled in two large clinical trials. Europace. 2014 Jun;16(6):812-9. doi: 10.1093/europace/eut361. Epub 2013 Dec 18. | |
| 24016511 |
| Label | URL |
|---|---|
| Homepage of the German AF Network | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 19, 2013 | |
| Reset | Oct 22, 2013 | |
| Release | Oct 25, 2013 | |
| Reset | Dec 13, 2013 | |
| Release | Feb 20, 2014 | |
| Reset | Apr 1, 2014 | |
| Release | Sep 8, 2020 | |
| Reset | Sep 28, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 19, 2013 | Oct 22, 2013 | |||
| Oct 25, 2013 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C437965 | olmesartan |
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| Time to persistent atrial fibrillation |
| 12 months follow up |
| Time to prescription of the recovery-medication | 12 months follow up |
| Number of hospitalizations for cardiovascular reasons (-> Endpoint review) | 12 months follow up |
| Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization | 12 months follow up |
| Number of cerebrovascular events | 12 months follow up |
| Quality of life | 12 months follow up |
| von Eisenhart Rothe A, Bielitzer M, Meinertz T, Limbourg T, Ladwig KH, Goette A. Predictors of discordance between physicians' and patients' appraisals of health-related quality of life in atrial fibrillation patients: findings from the Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation Trial. Am Heart J. 2013 Sep;166(3):589-96. doi: 10.1016/j.ahj.2013.05.020. Epub 2013 Jul 10. |
| 22157519 | Derived | Goette A, Schon N, Kirchhof P, Breithardt G, Fetsch T, Hausler KG, Klein HU, Steinbeck G, Wegscheider K, Meinertz T. Angiotensin II-antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):43-51. doi: 10.1161/CIRCEP.111.965178. Epub 2011 Dec 7. |
| Dec 13, 2013 |
| Feb 20, 2014 | Apr 1, 2014 |
| Sep 8, 2020 | Sep 28, 2020 |