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Persistent Atrial Fibrillation | Irbesartan and Adhesion Molecules in AF

Persistent Atrial Fibrillation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Persistent Atrial Fibrillation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:irbesartanIrbesartan-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:placeboPlacebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

2Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design

1Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design

Study Status

Unknown status

Start Date: May 2009

Completed Date: May 2010

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 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 Outcome: Number of cerebrovascular events

Study sponsors, principal investigator, and references

Principal Investigator: Andreas Goette, MD

Lead Sponsor: University of Magdeburg

Collaborator: Sanofi

More information:https://clinicaltrials.gov/show/NCT00613496

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