NCT01755936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 25, 2018

Status Verified

July 1, 2016

Enrollment Period

4 years

First QC Date

December 19, 2012

Last Update Submit

June 21, 2018

Conditions

Aortic Stenosis

Keywords

Aortic StenosisCardiac magnetic resonance imagingLate Gadolinium enhancementT1 mapping techniquesReplacement fibrosisDiffuse interstitial fibrosis

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular events

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

    1 year

Study Arms (2)

Controls

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

Other: Cardiac Magnetic Resonance ImagingOther: EchocardiographyOther: 72 hour Holter Monitor

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 ImagingOther: EchocardiographyOther: 72 hour Holter Monitor

Interventions

Cardiac Magnetic Resonance ImagingOTHER

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.

Aortic Stenosis patientsControls
EchocardiographyOTHER

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

Aortic Stenosis patientsControls
72 hour Holter MonitorOTHER

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

Aortic Stenosis patientsControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patients with aortic stenosis
  • Willing to undergo all investigations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 34642428DERIVED

  • 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.

    PMID: 29914867DERIVED

  • 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.

    PMID: 29196542DERIVED

  • 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.

    PMID: 28379401DERIVED

  • 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.

    PMID: 28017384DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood count and renal panel will be measured.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • David E Newby, MD PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

August 1, 2017

Last Updated

June 25, 2018

Record last verified: 2016-07

Locations

GB(1)