The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

Recruiting

• Conditions: Coronary Artery Disease; Cardiomyopathy

• Registration Number: NCT00930735
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure

Clinical significance Correlation with biomarkers and genetic markers

Detailed Description

Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2009-06-27
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23
• Primary Completion: 2020-04-30
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• presence of an ischaemic or non-ischaemic cardiomyopathic process
• no contraindication to contrast enhanced CMR
• GFR >30

Exclusion Criteria

• ESRF
• Contraindication to CM R

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	3 years
Ventricular arrhythmias	3 years
Unplanned heart failure admissions	3 years

Secondary Outcome Measures

Name	Time	Method
Ejection fraction	3
NYHA status	3

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom