Observational Study of the Remodelling Process Following Myocardial Infarct

Heart Failure Clinical Trial

Official title:

Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338156
• Other study ID #: StaHF461302
• Secondary ID: Helse Vest 91101
• Status: Completed
• Phase: N/A
• First received: June 16, 2006
• Last updated: July 27, 2015
• Start date: August 2003
• Est. completion date: September 2003

Study information

• Verified date: July 2010
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Observational

Clinical Trial Summary

This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

Description:

A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.

The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.

The data collected at the 3-year follow-up visit will be compared to data from the initial study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in the previous neurohormonal substudy of the OPTIMAAL trial

• Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

• Myocardial infarction within 3 months of visit 1.

• Significant primary valve disease, confirmed by ECHO cardiography,

• Autoimmune disease likely to cause an increase in collagen turnover

• Active cancer disease

• Immunosuppressive treatment,

• Significantly reduced liver function

• Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).

• Inability to cooperate during the 1 month follow up period.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Myocardial Infarct
• Myocardial Infarction

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Amersham Buchler, GmbH & Co KG, Helse Vest

Country where clinical trial is conducted

Norway,