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The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT01755936
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment
Aortic Stenosis Other: Cardiac Magnetic Resonance Imaging Other: Echocardiography Other: 72 hour Holter Monitor

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.

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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
Study Start Date : January 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Full blood count and renal panel will be measured.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755936


Locations
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United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
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Principal Investigator: David E Newby, MD PhD University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01755936     History of Changes
Other Study ID Numbers: 2010/R/CAR/05
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: July 2016

Keywords provided by University of Edinburgh:
Aortic Stenosis
Cardiac magnetic resonance imaging
Late Gadolinium enhancement
T1 mapping techniques
Replacement fibrosis
Diffuse interstitial fibrosis

Additional relevant MeSH terms:
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Fibrosis
Constriction, Pathologic
Aortic Valve Stenosis
Pathologic Processes
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction