The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

University of Edinburgh

Status: Completed

Conditions: Aortic Stenosis

Treatments: Other: Echocardiography; Other: Cardiac Magnetic Resonance Imaging; Other: 72 hour Holter Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT01755936

2010/R/CAR/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

203 participants in 2 patient groups

Controls

Description:

Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Treatment:

Other: 72 hour Holter Monitor

Other: Cardiac Magnetic Resonance Imaging

Other: Echocardiography

Aortic Stenosis patients

Description:

All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Treatment:

Other: 72 hour Holter Monitor

Other: Cardiac Magnetic Resonance Imaging

Other: Echocardiography