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Irbesartan and Adhesion Molecules in AF

Information source: University of Magdeburg
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Persistent Atrial Fibrillation

Intervention: irbesartan (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Magdeburg

Official(s) and/or principal investigator(s):
Andreas Goette, MD, Principal Investigator, Affiliation: University Hospital Magdeburg; Div of Cardiology

Overall contact:
Andreas Goette, MD, Phone: 00493916713225, Email: andreas.goette@medizin.uni-magdeburg.de

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Number of intermediate medical visits for cardiovascular reasons without hospitalization

Number of hospitalization for cardiovascular reasons and GFR

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Andreas Goette, MD, Phone: 00493916713225, Email: andreas.goette@medizin.uni-magdeburg.de

University Hospital Magdeburg; Div. of Cardiology, Magdeburg 39120, Germany; Recruiting
Veronika Raetzel, Phone: 0049 391 6701, Email: veronika.raetzel@medizin.uni-magdeburg.de
Additional Information

Starting date: May 2009
Last updated: May 28, 2009

Page last updated: February 07, 2013

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