Irbesartan and Adhesion Molecules in AF

NCT00613496 | Unknown Phase 4 DMC

• 2 other identifiers: AG-1-2007EUDRACTN: 2007-003262-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation; irbesartan; AT-II-antagonist; Adhesion Molecules; oxidative stress markers; hsCRP; ICAM; VCAM; MCP-1; vWF; TGFβ1; TNF-α; Interleukin-6; 8isoProstaglandinF2α

Outcome Measures

Primary Outcomes (1)

• 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)

  22 weeks

Secondary Outcomes (3)

• Number of cerebrovascular events

  22 weeks

• Number of intermediate medical visits for cardiovascular reasons without hospitalization

  22 weeks

• Number of hospitalization for cardiovascular reasons and GFR

  22 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

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

Drug: placebo

1

ACTIVE COMPARATOR

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

Drug: irbesartan

Interventions

irbesartan DRUG

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.

Also known as: Avapro, Aprovel, Carvea

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Magdeburg: lead
• Sanofi: collaborator

Study Sites (1)

University Hospital Magdeburg; Div. of Cardiology

Magdeburg, 39120, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Andreas Goette, MD

  University Hospital Magdeburg; Div of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Goette, MD

CONTACT

00493916713225; andreas.goette@medizin.uni-magdeburg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 29, 2009

Record last verified: 2009-05

Locations

DE (1)