Observational Study of the Remodelling Process Following Myocardial Infarct

Completed

• Conditions: Heart Failure; Myocardial Infarct

• Registration Number: NCT00338156
• Lead Sponsor: Helse Stavanger HF

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Status Verified: 2010-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway