Irbesartan and Adhesion Molecules in AF (CREATIVE-AF)

University of Magdeburg

Status and phase

Unknown

Phase 4

Conditions

Persistent Atrial Fibrillation

Treatments

Drug: irbesartan

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00613496

AG-1-2007

EUDRACTN: 2007-003262-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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