Left Ventricular Function After Acute Myocardial Infarction (AMI). Treatment With Angiotensin 2-Receptor Blockade (GLOBAL-Study)

This study is currently recruiting participants.

Verified by University of Southern Denmark, April 2007

Sponsors and Collaborators:	University of Southern Denmark Bristol-Myers Squibb
Information provided by:	University of Southern Denmark
ClinicalTrials.gov Identifier:	NCT00125645

Purpose

The purpose of this study is to compare changes in global left ventricular (LV) function after 3 months of treatment with irbesartan compared with usual care in patients with acute myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction. The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left ventricular function.

Condition	Intervention	Phase
Myocardial Infarction	Drug: Irbesartan	Phase IV

MedlinePlus related topics: Heart Attack

Drug Information available for: Irbesartan Angiotensin II Angiotensin II, ile(5)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Global Left Ventricular Function After Acute Myocardial Infarction. Treatment With the Angiotensin 2-Receptor Blocker Irbesartan

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:

Myocardial performance index (MPI) after 3 months treatment with irbesartan compared to usual care in acute myocardial infarction with wall motion score index (WMSI) >1.3 and MPI > 0.55

Estimated Enrollment:	200
Study Start Date:	March 2005
Estimated Study Completion Date:	July 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented AMI; MPI > 0.55
Randomized within 7 days of AMI
Written informed consent

Exclusion Criteria:

Age < 18 years
Any contraindications to angiotensin 2-receptor blockade
In patients with WMSI > 1.3 treatment with ACE-inhibitor or angiotensin 2-receptor blockers
In patients with WMSI <= 1.3 no initiated or planned treatment with an ACE-inhibitor. Treatment with an ACE-inhibitor must be started within 7 days
Pregnancy or women of childbearing potential who are not using an effective method of contraception
Other comorbid conditions that could influence the study
Currently receiving an experimental study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125645

Contacts

Contact: Allan T Pedersen, MD	+4523368158	Thimsen@dadlnet.dk
Contact: Kristian K Thomsen, MD	+4579182210	kkt@ribeamt.dk

Locations

Denmark
Kardiologisk Klinik, Centralsygehuset Esbjerg/Varde	Recruiting
Esbjerg, Denmark, 6700
Contact: Allan T Pedersen, MD +4523368158 Thimsen@dadlnet.dk
Principal Investigator: Allan T Pedersen, MD

Sponsors and Collaborators

University of Southern Denmark

Bristol-Myers Squibb

Investigators

Study Chair:

Kenneth Egstrup, Asst. Professor

Department of Medical Research, SHF Svendborg

More Information

Study ID Numbers:	VF 20040053, 2612
Study First Received:	July 29, 2005
Last Updated:	April 24, 2007
ClinicalTrials.gov Identifier:	NCT00125645
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University of Southern Denmark:

AMI
Left ventricular function
Myocardial performance index
Acute myocardial infarction (AMI)

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Irbesartan
Vascular Diseases

Ischemia
Angiotensin II
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009