Irbesartan and Adhesion Molecules in AF

Persistent Atrial Fibrillation Clinical Trial

— CREATIVE-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00613496
• Other study ID #: AG-1-2007
• Secondary ID: EUDRACTN: 2007-0
• Status: Recruiting
• Phase: Phase 4
• First received: January 31, 2008
• Last updated: May 28, 2009
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2009
• Source: University of Magdeburg
• Contact: Andreas Goette, MD
• Phone: 00493916713225
• Email: andreas.goette[@]medizin.uni-magdeburg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Drug:
• irbesartan
Irbesartan-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.
• placebo
Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.

Locations

Country	Name	City	State
Germany	University Hospital Magdeburg; Div. of Cardiology	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary target parameter is defined as reduction of systemic levels of oxidative stress markers and adhesion molecules (hsCRP, ICAM, VCAM, MCP-1, vWF, TGFß1, TNF-a, Interleukin-6, 8isoProstaglandinF2a)		22 weeks	No
Secondary	Number of cerebrovascular events		22 weeks	No
Secondary	Number of intermediate medical visits for cardiovascular reasons without hospitalization		22 weeks	No
Secondary	Number of hospitalization for cardiovascular reasons and GFR		22 weeks	No