- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613496
Irbesartan and Adhesion Molecules in AF (CREATIVE-AF)
Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Andreas Goette, MD
- Phone Number: 00493916713225
- Email: andreas.goette@medizin.uni-magdeburg.de
Study Locations
-
-
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Magdeburg, Germany, 39120
- Recruiting
- University Hospital Magdeburg; Div. of Cardiology
-
Contact:
- Veronika Raetzel
- Phone Number: 0049 391 6701
- Email: veronika.raetzel@medizin.uni-magdeburg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
22 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of cerebrovascular events
Time Frame: 22 weeks
|
22 weeks
|
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Time Frame: 22 weeks
|
22 weeks
|
Number of hospitalization for cardiovascular reasons and GFR
Time Frame: 22 weeks
|
22 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreas Goette, MD, University Hospital Magdeburg; Div of Cardiology
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG-1-2007
- EUDRACTN: 2007-003262-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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