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 eventsNumber 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
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