Aortic Valve StenosisNCT02792452
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed. The value of increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of valve compliance/resistance during stress… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to 31 Dec 2019
- 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: Suitable patients with moderate Aortic stenosis will be identified from the Echocardiography labs of the two trusts (London North West Healthcare NHS Trust and Royal Brompton Hospital) and will be approached for enrolment in the study.
Who may be able to join
- Age ≥18 years
- Moderate AS with AVA between 1-1.4cm2, and AVMG<40 millimetres of Mercury (mmHg); and
- Left Ventricular Ejection Fraction (LVEF) ≥50%; and
- Cardiac related symptoms; shortness of breath, chest pain or syncope.
Who cannot join
- Inability to exercise and undertake pharmacological stress, ie previously known intolerance to dobutamine;
- Severe aortic or mitral regurgitation or severe mitral stenosis;
- Significant pulmonary disease like severe (Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis;
- Atrial fibrillation;
- Inability to provide informed consent;
- Pregnancy;
- Other known non-cardiovascular disease associated with poor prognosis like metastatic cancer.
Trial locations and contacts
1 site in 1 country.
About this study
The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed. The value of increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population prognostication has to the investigators knowledge not been examined before. Similarly the additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially in combination with SE remains unclear.
Read the detailed description
The prevalence of aortic valve stenosis (AS) has increased over the last few decades due to improvement in life expectancy and a growing elderly population. A wealth of data is available on patients with severe AS, whereas the risk stratification and management of patients with symptomatic moderate AS remains contentious.
Stress echocardiography (SE) is a recognised tool for the risk stratification of patients with asymptomatic severe AS. Exercise is the preferred mode of stress in this group, as it provides important prognostic information- such as presence of symptoms, overall exercise capacity and precipitation of hypotension. Significant increase in mean gradient (MG) (MG >20mmHg) is an independent predictor of valve intervention or cardiovascular death, similar to older age, diabetes and high resting gradient and this is recognised in international guidelines as a parameter to risk stratify asymptomatic severe AS. The increase in MG in the context of increasing transvalvular flow during exercise is usually accompanied by little or no change in aortic valve area (AVA). Thus, mechanistically, the increase in MG is associated with worse outcome because it reflects the intrinsic non-compliance of the aortic valve and hence resistance. A compliant valve will open to accommodate the increased flow during stress, whereas a fixed valve orifice will not, resulting in increased gradients. It is therefore advised that these patients with asymptomatic severe AS and significant increase in MG during exercise may be reasonably considered for aortic valve intervention.
In moderate AS current guidelines recommend Aortic Valve replacement (AVR) only when other cardiac surgery (coronary artery bypass grafting) is planned (class IIa). This is because patients with moderate AS are a heterogeneous group with regard to the risk of adverse events: some have indeed rapid progression to severe AS, and/or Left Ventricular (LV) dysfunction and cardiovascular death, whereas others remain stable for many years. Overall moderate AS carries a substantial risk of death or valve intervention, with the estimated likelihood of event free survival at 4 years being 55-60%. Furthermore the presence of symptoms increases the overall likelihood of risk in moderate AS, as there is a significant difference in outcome between minimally symptomatic and symptomatic moderate AS. It maybe hypothesised that patients with moderate AS and symptoms in the absence of myocardial ischaemia due to flow-limiting coronary artery disease likely has the same valve hemodynamics as one with severe AS, particularly decreased valve compliance/increased resistance. These characteristics are likely to manifest during exercise when transvalvular flow is increased resulting in significant increase in gradient with little change in AVA. Accordingly, resting AVA and MG may not be the best parameters for determining suitability for valve intervention, particularly as the overall mortality of symptomatic moderate aortic stenosis approaches that of symptomatic severe AS. However, clear criteria that risk-stratify patients with symptomatic moderate AS and guide timing for intervention do not currently exist.
Accordingly the role of SE could be expanded beyond assessment of risk in asymptomatic severe AS to improve risk stratification in patients with symptomatic moderate AS. This is on the assumption that moderate AS associated with symptoms of breathlessness, chest pain or syncope is likely to have the same characteristics as severe AS. This means that during SE in moderate symptomatic AS one would expect the AVA to remain unchanged, the valve resistance to be elevated and the MG to increase.
Furthermore during SE apart from valve related indices that determine severity (AVA, MG), myocardial blood flow reserve (MBFR) has been shown to correlate with severity of AS; reduced MBFR is seen in severe AS whereas MBFR<1.8 has an accuracy of 85% for distinguishing severe from non-severe AS. It could therefore be that MBFR can also contribute in the risk stratification of symptomatic moderate AS.
It has been suggested that several other tests could contribute to the risk stratification of AS i.e. CT calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-terminal pro-brain natriuretic peptide (NT-proBNP). Specifically it has been shown that aortic valve calcium score correlates with AS severity and that there is moderate agreement between AVA as defined by American College of Cardiology (ACC) guidelines and the degree of AS determined from AV calcium score. Basal and global longitudinal strain (GLS) have been found to be independently associated both with the severity of AS and the presence of symptoms. Furthermore GLS can predict all-cause mortality in patients with AS and could therefore improve the identification of the optimal timing for AV replacement. The severity of AS in general has also been shown to correspond to an increase of carotid plaque and intima media thickness (IMT). Finally NT-proBNP values correlate with the severity of AS and in moderate AS, NT-proBNP can differentiate between symptomatic and asymptomatic status.
- Conditions
- Aortic Valve Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (cardiovascular/all cause)
Measured: between baseline and two years
Hospitalisation for heart failure
Measured: between baseline and two years
Aortic valve replacement (TAVI or surgical AVR)
Measured: between baseline and two years
Secondary outcomes (2)
Change in AS severity (progression to severe) as measured by quantitive echocardiography
Measured: Between baseline and one year
change in LV systolic function as measured by quantitive echocardiography
Measured: Between baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startSep 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, MD,DM,FRCP, Study director, London North West Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792452
- Sponsor's protocol ID
- AV AS-01
- Status last verified
- Jan 2020
- First submitted
- 19 May 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient scan results will be shared with their referring physician
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02792452
- Acronym / sponsor ID
- AV AS-01
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jun 2016 (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.
The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed. The value of increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population prognostication has to the investigators knowledge not been examined before. Similarly the additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially in combination with SE remains unclear.
Detailed description
The prevalence of aortic valve stenosis (AS) has increased over the last few decades due to improvement in life expectancy and a growing elderly population. A wealth of data is available on patients with severe AS, whereas the risk stratification and management of patients with symptomatic moderate AS remains contentious.
Stress echocardiography (SE) is a recognised tool for the risk stratification of patients with asymptomatic severe AS. Exercise is the preferred mode of stress in this group, as it provides important prognostic information- such as presence of symptoms, overall exercise capacity and precipitation of hypotension. Significant increase in mean gradient (MG) (MG >20mmHg) is an independent predictor of valve intervention or cardiovascular death, similar to older age, diabetes and high resting gradient and this is recognised in international guidelines as a parameter to risk stratify asymptomatic severe AS. The increase in MG in the context of increasing transvalvular flow during exercise is usually accompanied by little or no change in aortic valve area (AVA). Thus, mechanistically, the increase in MG is associated with worse outcome because it reflects the intrinsic non-compliance of the aortic valve and hence resistance. A compliant valve will open to accommodate the increased flow during stress, whereas a fixed valve orifice will not, resulting in increased gradients. It is therefore advised that these patients with asymptomatic severe AS and significant increase in MG during exercise may be reasonably considered for aortic valve intervention.
In moderate AS current guidelines recommend Aortic Valve replacement (AVR) only when other cardiac surgery (coronary artery bypass grafting) is planned (class IIa). This is because patients with moderate AS are a heterogeneous group with regard to the risk of adverse events: some have indeed rapid progression to severe AS, and/or Left Ventricular (LV) dysfunction and cardiovascular death, whereas others remain stable for many years. Overall moderate AS carries a substantial risk of death or valve intervention, with the estimated likelihood of event free survival at 4 years being 55-60%. Furthermore the presence of symptoms increases the overall likelihood of risk in moderate AS, as there is a significant difference in outcome between minimally symptomatic and symptomatic moderate AS. It maybe hypothesised that patients with moderate AS and symptoms in the absence of myocardial ischaemia due to flow-limiting coronary artery disease likely has the same valve hemodynamics as one with severe AS, particularly decreased valve compliance/increased resistance. These characteristics are likely to manifest during exercise when transvalvular flow is increased resulting in significant increase in gradient with little change in AVA. Accordingly, resting AVA and MG may not be the best parameters for determining suitability for valve intervention, particularly as the overall mortality of symptomatic moderate aortic stenosis approaches that of symptomatic severe AS. However, clear criteria that risk-stratify patients with symptomatic moderate AS and guide timing for intervention do not currently exist.
Accordingly the role of SE could be expanded beyond assessment of risk in asymptomatic severe AS to improve risk stratification in patients with symptomatic moderate AS. This is on the assumption that moderate AS associated with symptoms of breathlessness, chest pain or syncope is likely to have the same characteristics as severe AS. This means that during SE in moderate symptomatic AS one would expect the AVA to remain unchanged, the valve resistance to be elevated and the MG to increase.
Furthermore during SE apart from valve related indices that determine severity (AVA, MG), myocardial blood flow reserve (MBFR) has been shown to correlate with severity of AS; reduced MBFR is seen in severe AS whereas MBFR<1.8 has an accuracy of 85% for distinguishing severe from non-severe AS. It could therefore be that MBFR can also contribute in the risk stratification of symptomatic moderate AS.
It has been suggested that several other tests could contribute to the risk stratification of AS i.e. CT calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-terminal pro-brain natriuretic peptide (NT-proBNP). Specifically it has been shown that aortic valve calcium score correlates with AS severity and that there is moderate agreement between AVA as defined by American College of Cardiology (ACC) guidelines and the degree of AS determined from AV calcium score. Basal and global longitudinal strain (GLS) have been found to be independently associated both with the severity of AS and the presence of symptoms. Furthermore GLS can predict all-cause mortality in patients with AS and could therefore improve the identification of the optimal timing for AV replacement. The severity of AS in general has also been shown to correspond to an increase of carotid plaque and intima media thickness (IMT). Finally NT-proBNP values correlate with the severity of AS and in moderate AS, NT-proBNP can differentiate between symptomatic and asymptomatic status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suitable patients with moderate Aortic stenosis will be identified from the Echocardiography labs of the two trusts (London North West Healthcare NHS Trust and Royal Brompton Hospital) and will be approached for enrolment in the study.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Moderate AS with AVA between 1-1.4cm2, and AVMG<40 millimetres of Mercury (mmHg); and
- Left Ventricular Ejection Fraction (LVEF) ≥50%; and
- Cardiac related symptoms; shortness of breath, chest pain or syncope.
Key exclusion criteria (7 listed)
- Inability to exercise and undertake pharmacological stress, ie previously known intolerance to dobutamine;
- Severe aortic or mitral regurgitation or severe mitral stenosis;
- Significant pulmonary disease like severe (Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis;
- Atrial fibrillation;
- Inability to provide informed consent;
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
Death (cardiovascular/all cause)
Time frame: between baseline and two years
Hospitalisation for heart failure
Time frame: between baseline and two years
Aortic valve replacement (TAVI or surgical AVR)
Time frame: between baseline and two years
2 secondary outcomes
Change in AS severity (progression to severe) as measured by quantitive echocardiography
Time frame: Between baseline and one year
change in LV systolic function as measured by quantitive echocardiography
Time frame: Between baseline and one year
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 12 Feb 2020.
- Individual participant dataSharing planned: Yes. Patient scan results will be shared with their referring physician
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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.
Roxy Senior, MD,DM,FRCP study director
London North West Healthcare NHS Trust
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 Valve Stenosis, run by London North West Healthcare NHS Trust 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 7 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 12 Feb 2020. 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?
Death (cardiovascular/all cause) (time frame: between baseline and two years). The study lists 3 primary outcomes in all. 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 12 Feb 2020.