The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

June 21, 2018 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SB
        • University of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 240 individuals will be recruited. This includes 48 individuals who do not have aortic stenosis. A total of 192 individuals with aortic stenosis will be recruited:

  1. Mild aortic stenosis, n=48
  2. Moderate aortic stenosis, n=48
  3. Severe aortic stenosis, n=48
  4. Symptomatic aortic stenosis with planned valve replacement, n=48

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
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.
Other: Echocardiography
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
Other: 72 hour Holter Monitor
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis
Aortic Stenosis patients
All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
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.
Other: Echocardiography
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
Other: 72 hour Holter Monitor
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 1 year
Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: David E Newby, MD PhD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/R/CAR/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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