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The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01755936
Enrollment
203
Registered
2012-12-24
Start date
2012-01-31
Completion date
2017-08-31
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Aortic Stenosis, Cardiac magnetic resonance imaging, Late Gadolinium enhancement, T1 mapping techniques, Replacement fibrosis, Diffuse interstitial fibrosis

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.

Interventions

OTHERCardiac 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.

OTHEREchocardiography

Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.

OTHER72 hour Holter Monitor

This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Sponsors

British Heart Foundation
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular events1 yearCardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026