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Irbesartan and Adhesion Molecules in AF (CREATIVE-AF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Magdeburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00613496
First Posted: February 13, 2008
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
University of Magdeburg
  Purpose
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.

Condition Intervention Phase
Persistent Atrial Fibrillation Drug: irbesartan Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • 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) [ Time Frame: 22 weeks ]

Secondary Outcome Measures:
  • Number of cerebrovascular events [ Time Frame: 22 weeks ]
  • Number of intermediate medical visits for cardiovascular reasons without hospitalization [ Time Frame: 22 weeks ]
  • Number of hospitalization for cardiovascular reasons and GFR [ Time Frame: 22 weeks ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
Drug: placebo
Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
Active Comparator: 1
Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
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.
Other Names:
  • Avapro
  • Aprovel
  • Carvea

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613496


Contacts
Contact: Andreas Goette, MD 00493916713225 andreas.goette@medizin.uni-magdeburg.de

Locations
Germany
University Hospital Magdeburg; Div. of Cardiology Recruiting
Magdeburg, Germany, 39120
Contact: Veronika Raetzel    0049 391 6701    veronika.raetzel@medizin.uni-magdeburg.de   
Sponsors and Collaborators
University of Magdeburg
Sanofi
Investigators
Principal Investigator: Andreas Goette, MD University Hospital Magdeburg; Div of Cardiology
  More Information

Responsible Party: Andreas Goette, MD, University Hospital Magdeburg
ClinicalTrials.gov Identifier: NCT00613496     History of Changes
Other Study ID Numbers: AG-1-2007
EUDRACTN: 2007-003262-17
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by University of Magdeburg:
Atrial Fibrillation
irbesartan
AT-II-antagonist
Adhesion Molecules
oxidative stress markers
hsCRP
ICAM
VCAM
MCP-1
vWF
TGFβ1
TNF-α
Interleukin-6
8isoProstaglandinF2α

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action