The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
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Purpose
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 | Intervention |
|---|---|
|
Aortic Stenosis |
Other: Cardiac Magnetic Resonance Imaging Other: Echocardiography Other: 72 hour Holter Monitor |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Myocardial Fibrosis in Patients With Aortic Stenosis |
- Cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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:
- Mild aortic stenosis, n=48
- Moderate aortic stenosis, n=48
- Severe aortic stenosis, n=48
- Symptomatic aortic stenosis with planned valve replacement, n=48
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
Contacts and Locations| Contact: Calvin Chin, MD | 0131 242 6422 | cchin03m@gmail.com |
| United Kingdom | |
| University of Edinburgh | Recruiting |
| Edinburgh, Midlothian, United Kingdom, EH16 4SB | |
| Contact: Calvin Chin, MD 0131 242 6422 cchin03m@gmail.com | |
| Principal Investigator: | David E Newby, MD PhD | University of Edinburgh |
More Information
No publications provided
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01755936 History of Changes |
| Other Study ID Numbers: | 2010/R/CAR/05 |
| Study First Received: | December 19, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United Kingdom: National Health Service |
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:
|
Aortic Valve Stenosis Constriction, Pathologic Fibrosis Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013