Aortic StenosisMODE-ASNCT03332745
Mechanism of Decompensation Evaluation - Aortic Stenosis
An observational study of Aortic Stenosis and Myocardial Fibrosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Myocardial Fibrosis, Left Ventricular Hypertrophy
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 31 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for surgery for aortic valve disease (aortic stenosis group) and those referred for non-aortic valve cardiac surgery or elective ascending aorta surgery (control group)
Who may be able to join
- Age over 18
- Severe aortic stenosis with planned aortic valve replacement
- Age over 18
- Planned non-aortic valve cardiac or elective ascending aorta surgery
Who cannot join
- Coexistent severe aortic or mitral regurgitation
- Coexistent mitral stenosis greater than mild in severity
- Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
- Acute pulmonary oedema or cardiogenic shock
- Coexistent hypertrophic cardiomyopathy
- Unable to give informed consent
Show all 11Show fewer
- Significant aortic valve disease (mild aortic stenosis / regurgitation or greater)
- Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
- Acute pulmonary oedema or cardiogenic shock
- Coexistent hypertrophic cardiomyopathy
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh / NHS Lothian
Edinburgh, Midlothian, EH164SB
About this study
Official title: Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis
Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention.
In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.
- Keywords
- Troponin
- Medical subject headings
- Aortic Valve Stenosis, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe aortic stenosis | Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery | |
| Control group | Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of blood biomarkers with pathological changes on myocardial biopsy
Correlation between biomarkers (e.g. high sensitivity troponin I, BNP) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)
Measured: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Secondary outcomes (1)
Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy
Correlation between imaging measures (e.g. LV diastolic function, longitudinal systolic function, ECG LVH criteria, ECG strain pattern) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)
Measured: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Sep 2018
- Primary completion12 Aug 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell J Everett, MBBS, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332745
- Sponsor's protocol ID
- E161633
- Acronym
- MODE-AS
- Status last verified
- May 2024
- First submitted
- 30 Oct 2017
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03332745
- Acronym / sponsor ID
- MODE-AS / E161633
- Keywords
- Troponin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention.
In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe aortic stenosis | – | –Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery |
| Control group | – | –Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for surgery for aortic valve disease (aortic stenosis group) and those referred for non-aortic valve cardiac surgery or elective ascending aorta surgery (control group)
Key inclusion criteria (4 listed)
- Age over 18
- Severe aortic stenosis with planned aortic valve replacement
- Age over 18
- Planned non-aortic valve cardiac or elective ascending aorta surgery
Key exclusion criteria (11 listed)
- Coexistent severe aortic or mitral regurgitation
- Coexistent mitral stenosis greater than mild in severity
- Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
- Acute pulmonary oedema or cardiogenic shock
- Coexistent hypertrophic cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of blood biomarkers with pathological changes on myocardial biopsy
Time frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Correlation between biomarkers (e.g. high sensitivity troponin I, BNP) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)
1 secondary outcome
Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy
Time frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
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 13 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Russell J Everett, MBBS 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 and Myocardial Fibrosis, 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 4 inclusion and 11 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 13 May 2024. 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?
Correlation of blood biomarkers with pathological changes on myocardial biopsy (time frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2024.