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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACTN: 2007-003262-17 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Experimental data suggest that angiotensin II-antagonists reduce the atrial expression of prothrombotic adhesion molecules and oxidative stress parameters. The present study is designed to investigate the effects on angiotensin II-antagonist irbesartan to reduce the amounts of circulating oxidative stress markers and adhesion molecules in patients with persistent atrial fibrillation.
Primary Objective:
The aim of the study is to assess that blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules by more than 25% compared to placebo in patients with persistent/permanent atrial fibrillation.
Primary Target Parameter:
The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules (hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α)
Secondary Target Parameter:
The secondary Target Parameters are defined as number of cerebrovascular events, number of intermediate medical visits for cardiovascular reasons without hospitalisation, number of hospitalisations for cardiovascular reasons and GFR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design |
|
| 1 | Active Comparator | Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irbesartan | Drug | Irbesartan-tablet (150 mg) 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8 if no contraindication for up titration (investigator will decide on the basis of creatinin, urea and potassium after taking a blood sample) for 9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules (hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α) | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cerebrovascular events | 22 weeks | |
| Number of intermediate medical visits for cardiovascular reasons without hospitalization | 22 weeks | |
| Number of hospitalization for cardiovascular reasons and GFR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Goette, MD | Contact | 00493916713225 | andreas.goette@medizin.uni-magdeburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Goette, MD | University Hospital Magdeburg; Div of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Magdeburg; Div. of Cardiology | Recruiting | Magdeburg | 39120 | Germany |
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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 |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| placebo | Drug | Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8. |
|
| 22 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |