The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

NCT ID: NCT01755936

Last Updated: 2018-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Controls

Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Cardiac Magnetic Resonance Imaging

Intervention Type 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

Intervention Type OTHER

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

72 hour Holter Monitor

Intervention Type OTHER

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

Cardiac Magnetic Resonance Imaging

Intervention Type 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

Intervention Type OTHER

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

72 hour Holter Monitor

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Echocardiography

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

Intervention Type OTHER

72 hour Holter Monitor

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David E Newby, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status

Countries

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United Kingdom

References

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Vassiliou VS, Pavlou M, Malley T, Halliday BP, Tsampasian V, Raphael CE, Tse G, Vieira MS, Auger D, Everett R, Chin C, Alpendurada F, Pepper J, Pennell DJ, Newby DE, Jabbour A, Dweck MR, Prasad SK. A novel cardiovascular magnetic resonance risk score for predicting mortality following surgical aortic valve replacement. Sci Rep. 2021 Oct 12;11(1):20183. doi: 10.1038/s41598-021-99788-7.

Reference Type DERIVED
PMID: 34642428 (View on PubMed)

Everett RJ, Tastet L, Clavel MA, Chin CWL, Capoulade R, Vassiliou VS, Kwiecinski J, Gomez M, van Beek EJR, White AC, Prasad SK, Larose E, Tuck C, Semple S, Newby DE, Pibarot P, Dweck MR. Progression of Hypertrophy and Myocardial Fibrosis in Aortic Stenosis: A Multicenter Cardiac Magnetic Resonance Study. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007451. doi: 10.1161/CIRCIMAGING.117.007451.

Reference Type DERIVED
PMID: 29914867 (View on PubMed)

Anand A, Chin C, Shah ASV, Kwiecinski J, Vesey A, Cowell J, Weber E, Kaier T, Newby DE, Dweck M, Marber MS, Mills NL. Cardiac myosin-binding protein C is a novel marker of myocardial injury and fibrosis in aortic stenosis. Heart. 2018 Jul;104(13):1101-1108. doi: 10.1136/heartjnl-2017-312257. Epub 2017 Dec 1.

Reference Type DERIVED
PMID: 29196542 (View on PubMed)

Kwiecinski J, Chin CWL, Everett RJ, White AC, Semple S, Yeung E, Jenkins WJ, Shah ASV, Koo M, Mirsadraee S, Lang CC, Mills N, Prasad SK, Jansen MA, Japp AG, Newby DE, Dweck MR. Adverse prognosis associated with asymmetric myocardial thickening in aortic stenosis. Eur Heart J Cardiovasc Imaging. 2018 Mar 1;19(3):347-356. doi: 10.1093/ehjci/jex052.

Reference Type DERIVED
PMID: 28379401 (View on PubMed)

Chin CWL, Everett RJ, Kwiecinski J, Vesey AT, Yeung E, Esson G, Jenkins W, Koo M, Mirsadraee S, White AC, Japp AG, Prasad SK, Semple S, Newby DE, Dweck MR. Myocardial Fibrosis and Cardiac Decompensation in Aortic Stenosis. JACC Cardiovasc Imaging. 2017 Nov;10(11):1320-1333. doi: 10.1016/j.jcmg.2016.10.007. Epub 2016 Dec 21.

Reference Type DERIVED
PMID: 28017384 (View on PubMed)

Other Identifiers

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2010/R/CAR/05

Identifier Type: -

Identifier Source: org_study_id

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