The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Aortic Stenosis Clinical Trial

Official title:

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755936
• Other study ID #: 2010/R/CAR/05
• Status: Completed
• Start date: January 2012
• Est. completion date: August 2017

Study information

• Verified date: July 2016
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: August 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Fibrosis

Intervention

Other:
• Cardiac Magnetic Resonance Imaging
For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated.
• Echocardiography
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
• 72 hour Holter Monitor
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh	Midlothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.	1 year