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Irbesartan and Adhesion Molecules in AF (CREATIVE-AF)

Primary Purpose

Persistent Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
irbesartan
placebo
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, irbesartan, AT-II-antagonist, Adhesion Molecules, oxidative stress markers, hsCRP, ICAM, VCAM, MCP-1, vWF, TGFβ1, TNF-α, Interleukin-6, 8isoProstaglandinF2α

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Magdeburg; Div. of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2

1

Arm Description

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

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

Outcomes

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)

Secondary Outcome Measures

Number of cerebrovascular events
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Number of hospitalization for cardiovascular reasons and GFR

Full Information

First Posted
January 31, 2008
Last Updated
May 28, 2009
Sponsor
University of Magdeburg
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00613496
Brief Title
Irbesartan and Adhesion Molecules in AF
Acronym
CREATIVE-AF
Official Title
Impact of Irbesartan on Oxidative Stress and C-Reactive Protein Levels in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Magdeburg
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
Arm Title
1
Arm Type
Active Comparator
Arm Description
Irbesartan treatment in each patient during the study (9 weeks) using an intraindividual cross-over design
Intervention Type
Drug
Intervention Name(s)
irbesartan
Other Intervention Name(s)
Avapro, Aprovel, Carvea
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo-tablet, 1 in the morning for 7 days, 2 tablets (1 in the morning and 1 in the evening) after day 8.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of cerebrovascular events
Time Frame
22 weeks
Title
Number of intermediate medical visits for cardiovascular reasons without hospitalization
Time Frame
22 weeks
Title
Number of hospitalization for cardiovascular reasons and GFR
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Goette, MD
Phone
00493916713225
Email
andreas.goette@medizin.uni-magdeburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Goette, MD
Organizational Affiliation
University Hospital Magdeburg; Div of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Magdeburg; Div. of Cardiology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronika Raetzel
Phone
0049 391 6701
Email
veronika.raetzel@medizin.uni-magdeburg.de

12. IPD Sharing Statement

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Irbesartan and Adhesion Molecules in AF

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