The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Completed

• Conditions: Aortic Stenosis
• Interventions: Other: Cardiac Magnetic Resonance Imaging; Other: Echocardiography; Other: 72 hour Holter Monitor

• Registration Number: NCT01755936
• Lead Sponsor: University of Edinburgh

Brief Summary

Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis. In symptomatic individuals, valve replacement is often the only effective treatment. However, there are no good markers to identify patients who may benefit from early surgery before symptoms developed. The purpose of the study is to test the hypothesis that the presence heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome in patients with aortic stenosis, and thus may be helpful in identifying patients for early valve replacement.

Detailed Description

Congestive heart failure and sudden cardiac death are associated complications of aortic stenosis. Currently, the indications for valvular replacement are based on the valvular severity evaluated by echocardiography and the presence of symptoms. There is some evidence to suggest the presence of myocardial fibrosis is associated with a poor outcome in patients with aortic stenosis. The aim of this prospective study is to investigate the prognostic implications of myocardial fibrosis in patients with aortic stenosis. The presence of myocardial fibrosis will be identified by delayed enhancement with the cardiac magnetic resonance imaging at 3T. We will also be evaluating the application of T1 mapping techniques to detect diffuse myocardial fibrosis.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Primary Completion: 2016-01
• Status Verified: 2016-07
• Study Completion: 2017-08
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Patients with aortic stenosis
• Willing to undergo all investigations

Exclusion Criteria

• Coexisting mitral valvular heart disease and aortic regurgitation (more than moderate severity)
• Active medical conditions: ongoing heart failure, infection
• Significant comorbidities: advanced malignancy with limited life expectancy
• Unable to give informed consent
• Contraindication for cardiac magnetic resonance imaging: impaired renal function, pacemaker, claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic Stenosis patients	Echocardiography	All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Controls	Cardiac Magnetic Resonance Imaging	Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Controls	Echocardiography	Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Aortic Stenosis patients	Cardiac Magnetic Resonance Imaging	All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Controls	72 hour Holter Monitor	Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Aortic Stenosis patients	72 hour Holter Monitor	All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	1 year	Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.

Trial Locations

Locations (1)

University of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom