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OpenTrials
Completed

NCT Number: NCT01755936

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Magnetic Resonance Imaging

Other

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

Other

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

72 hour Holter Monitor

Other

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

Primary outcomes

  1. Cardiovascular events

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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