Status:
UNKNOWN
Irbesartan and Adhesion Molecules in AF
Lead Sponsor:
University of Magdeburg
Collaborating Sponsors:
Sanofi
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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% compa...
Eligibility Criteria
Inclusion
- Patients with persistent/permanent AF (\>2 months)
- CHADS2 Score ≥2
- Age ≥18
- Patient informed orally and in writing
- Written informed consent of the patient
- Patients who are anticipated to show sufficient compliance in following the study protocol
- Patients must agree to undergo the 148 days clinical follow-up
- Patients who are mentally and linguistically able to understand the aim of the study and the associated risks and benefits of the treatment. The patients, by providing informed consent, agree to this treatment as stated in the patient informed consent document.
Exclusion
- Strong clinical evidence that prevents the temporary pause of therapy with AT II antagonists
- Symptomatic bradycardia
- Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardia algorithm in use
- Cardiac surgery or cardiac catheter ablation within the last 3 months prior to randomisation
- Typical angina pectoris symptoms at rest or during exercise
- Known coronary artery disease with indication for intervention
- Symptomatic peripheral vascular disease
- Left ventricular ejection fraction \<35%
- Myocardial infarction within 6 months prior to randomisation
- Diastolic blood pressure \>110mmHg at rest
- Symptomatic arterial hypotension
- Known renal artery stenosis
- Serum creatinin \>1.8mval/l
- Chronic inflammatory disease
- Acute inflammatory disease (CRP \>20mg/L)
- Relevant hepatic or pulmonary disorders
- Hyperthyreosis manifested clinically and in laboratory
- Known drug intolerance for AT II inhibitors
- Females who are pregnant or breast feeding
- Females of childbearing potential who are not using a scientifically accepted method of contraception
- Participation in a clinical trial within the last 30 days prior to randomisation
- Drug addiction or chronic alcohol abuse
- Cancer or other disease, which inevitably leads to death
- Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study, evidence of an uncooperative attitude
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00613496
Start Date
May 1 2009
End Date
May 1 2010
Last Update
May 29 2009
Active Locations (1)
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1
University Hospital Magdeburg; Div. of Cardiology
Magdeburg, Germany, 39120