NCT00613496

Irbesartan and Adhesion Molecules in AF

Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Magdeburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	irbesartan	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.
DRUG	placebo	Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-02-13
• Last updated: 2009-05-29

Locations

1 site across 1 country: Germany