Aortic StenosisNCT01755936
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
An observational study of Aortic Stenosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Cardiac Magnetic Resonance Imaging, Echocardiography and 72 hour Holter Monitor
- How many people
- 203 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with aortic stenosis
- Willing to undergo all investigations
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Midlothian, EH16 4SB
About this study
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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- Cardiac Magnetic Resonance Imaging, Echocardiography, 72 hour Holter Monitor
- Keywords
- Aortic Stenosis, Cardiac magnetic resonance imaging, Late Gadolinium enhancement, T1 mapping techniques, Replacement fibrosis, Diffuse interstitial fibrosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EchocardiographyOther
Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
72 hour Holter MonitorOther
This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Controls | Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring Receives: Other: Cardiac Magnetic Resonance Imaging; Other: Echocardiography; Other: 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 Receives: Other: Cardiac Magnetic Resonance Imaging; Other: Echocardiography; Other: 72 hour Holter Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- David E Newby, MD PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755936
- Sponsor's protocol ID
- 2010/R/CAR/05
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2012
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34642428Everett 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.
PubMed 29914867Anand 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.
PubMed 29196542Kwiecinski 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.
PubMed 28379401Chin 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.
PubMed 28017384
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01755936
- Acronym / sponsor ID
- 2010/R/CAR/05
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Cardiac magnetic resonance imaging, Late Gadolinium enhancement, T1 mapping techniques, Replacement fibrosis, Diffuse interstitial fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Other: Cardiac Magnetic Resonance Imaging, Other: Echocardiography, Other: 72 hour Holter MonitorPatients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring |
| Aortic Stenosis patients | – | Other: Cardiac Magnetic Resonance Imaging, Other: Echocardiography, Other: 72 hour Holter MonitorAll patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with aortic stenosis
- Willing to undergo all investigations
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance ImagingFor 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 | Aortic Stenosis patients, Controls |
| EchocardiographyAssessment of aortic stenosis severity. Also evaluate diastolic and systolic function. | Other | Aortic Stenosis patients, Controls |
| 72 hour Holter MonitorThis will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis | Other | Aortic Stenosis patients, Controls |
Primary outcome
Cardiovascular events
Time frame: 1 year
Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 34642428Vassiliou 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.
- Derived from this study: PubMed 29914867Everett 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.
- Derived from this study: PubMed 29196542Anand 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.
- Derived from this study: PubMed 28379401Kwiecinski 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.
- Derived from this study: PubMed 28017384Chin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby, MD PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755936, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.