NCT00125645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 8, 2018

Status Verified

April 1, 2007

Enrollment Period

6.5 years

First QC Date

July 29, 2005

Last Update Submit

May 2, 2018

Conditions

Myocardial Infarction

Keywords

AMILeft ventricular functionMyocardial performance indexAcute myocardial infarction (AMI)

Outcome Measures

Primary Outcomes (1)

  • Left ventricular function

    3 months

Study Arms (1)

Irbesartan

EXPERIMENTAL

Tablet Irbesartan 150 mg once daily

Drug: Irbesartan Oral Tablet

Interventions

Irbesartan Oral TabletDRUG
Irbesartan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kardiologisk Klinik, Centralsygehuset Esbjerg/Varde

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Kenneth Egstrup, Asst. Professor

    Department of Medical Research, SHF Svendborg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Comparison with EF
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

March 1, 2005

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 8, 2018

Record last verified: 2007-04

Locations

DK(1)