Impact of irbesartan on oxidative stress and C-reactive protein levels in patients with persistent atrial fibrillation - CREATIVE-AF
- Conditions
- Blocking the angiotensin II type 1 receptor reduces systemic levels of oxidative stress markers and adhesion molecules compared to placebo in patients with persistent/permanent atrial fibrillation.
- Registration Number
- EUCTR2007-003262-17-DE
- Lead Sponsor
- niversity Hospital Magdeburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Patients with persistent/permanent AF (> 2 months)
CHADS2 Score > 2
Age ³ 18
Patient informed orally and in writing
Written informed consent of the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
§Strong clinical evidence that prevents the temporary pause of therapy with AT II antagonists
§Symptomatic bradycardia
§Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
§Cardiac surgery or cardiac catheter ablation within the last 3 months
§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 of screening
§Diastolic blood pressure > 110mm Hg at rest
§Symptomatic arterial hypotension
§Known renal artery stenosis
§serum creatinin > 1.8 mval/l
§chronic inflammatory disease
§acute inflammatory disease (hsCRP > 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
§Drug addiction or chronic alcohol abuse
§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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method