Congenital Aortic StenosisCASNCT05252351
Cardiac Imaging in Adults With Congenital Aortic Stenosis
An observational study of Congenital Aortic Stenosis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy (LVH), myocardial stiffness and myocardial fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Aortic Stenosis
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jan 2022to 1 Nov 2026
- 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: The study population consists of adult ConAoS patients, who are visiting the outpatient clinic of the Erasmus MC.
Who may be able to join
None listed.
Who cannot join
- Patients with severe aortic regurgitation
- Presence of any of the following contra-indications for MRI
- Contra-indication to gadolinium based contrast media (eGFR <30 ml/min or contrast allergy)
- Other contra-indications such as presence of pacemaker/implantable cardioverter defibrillator, severe claustrophobia or pregnancy
- Patients known with or previously treated because of aortic coarctation.
- Patients known with genetic syndromes or connective tissue disorders
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Cardiac Imaging in Congenital Aortic Stenosis - Unravelling Risk Factors and Predicting Clinical Outcome
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy (LVH), myocardial stiffness and myocardial fibrosis.
Read the detailed description
Congenital aortic stenosis (ConAoS) accounts for 4-8% of all congenital cardiac diagnoses. It is often caused by a bicuspid aortic valve (BAV), which has an estimated prevalence of 0.5-2% in the general population. Patients with ConAoS may remain asymptomatic, but gradual deterioration of the stenosis and the strong association of BAV with aortic dilatation contributes to important morbidity and mortality. The prevalent nature of this heart defect implies an important health problem resulting in hospitalization and (re-) interventions. As it is still largely unknown which markers predict adverse outcome, the aim of this study is to evaluate trends in imaging and biomarkers in this patient population and their relation with clinical outcome.
It is increasingly acknowledged that aortic stenosis is not only a disease of the valve, but also of the left ventricle (LV) and the aorta. In the course of disease progression, pressure overload and ventricular wall stress lead to remodeling of the LV, which eventually leads to left ventricular hypertrophy (LVH) and myocardial fibrosis. Although these processes have been described in patients with aortic stenosis, little is known about the prevalence and prognostic relevance of LVH and myocardial fibrosis in patients with ConAoS, who are often relatively young. Applying upcoming innovative imaging modalities such as high frame rate echocardiography and T1-mapping in patients with ConAoS will increase our knowledge on tissue characterization, which in turn will facilitate identifying patients at high risk for complications and rapid disease progression.
The CAS study is a clinical observational study investigating the effects of ConAoS on the left ventricular function and the prevalence, pattern and expanse of LVH, myocardial stiffness and myocardial fibrosis. Moreover, the prognostic capacity of the presence of these pathological processes will be assessed, correlating findings at baseline to clinical outcome by assessing the occurrence of cardiovascular events and all-cause mortality during 3-year clinical follow-up. The investigators will unravel biomarker and imaging predictors for myocardial dysfunction (systolic and diastolic) with specific attention for male-female differences. This newly gained knowledge will enable the investigators to improve and individualize current treatment protocols and derive novel therapeutic strategies for adult patients with ConAoS.
- Conditions
- Congenital Aortic Stenosis
- Keywords
- Congenital Aortic Stenosis, Bicuspid Aortic Valve, Left ventricular function, Cardiac imaging, Myocardial tissue characterization
- Medical subject headings
- Bicuspid Aortic Valve Disease
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 |
|---|---|---|
| Adults with congenital aortic stenosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocardial fibrosis
Assessed at baseline using cardiovascular magnetic resonance imaging (late gadolinium enhancement (LGE) and T1 mapping pre- and post-contrast)
Measured: Baseline
Secondary outcomes (11)
Left ventricular function
This outcome is measured by strain measurements using echocardiography and cardiovascular magnetic resonance imaging (CMR)
Measured: Baseline
Shear wave velocity
Shear wave velocity is measured using high frame rate echocardiography
Measured: Baseline
Physical activity in daily life
This outcome is measured by the following questionnaire: Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
Measured: Baseline
Quality of life (SF-36)
This outcome is assessed by using the SF-36 questionnaire
Measured: Baseline
Occurence of ventricular arrhythmias
This outcome is assessed by the occurence of ventricular ectopies and non-sustained ventricular tachycardia (VT) on Holter ECG for 48 hours.
Measured: Baseline
Conduction abnormalities on ECG
For this outcome the conduction times on ECG will be measured
Measured: Baseline
All-cause mortality
Measured: 3 years
Cardiovascular events
Incidents of heart failure, arrhythmias, endocarditis, aortopathy (aortic dissection and/or aortic aneurysm), (re-) interventions and (re-) operations of the aortic valve and/or ascending aorta and hospitalizations for other cardiac reasons
Measured: 3 years
Aortic flow patterns
This outcome is measured using 4D flow CMR
Measured: Baseline
Blood biomarkers
Measured: Baseline
Fear of movement
This outcome is measured using the following questionnaire: Tampa Scale for Kinesiophobia (TSK-NL Heart)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start13 Jan 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Principal investigator, Dr. Annemien E. van den Bosch, Erasmus Medical Center
- Investigators
- Annemien E van den Bosch, MD, PHD, Principal investigator, Erasmus Medical CenterAlexander Hirsch, MD, PHD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252351
- Sponsor's protocol ID
- CAS study
- Acronym
- CAS
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Imaging in Congenital Aortic Stenosis - Unravelling Risk Factors and Predicting Clinical Outcome
- ClinicalTrials.gov ID
- NCT05252351
- Acronym / sponsor ID
- CAS / CAS study
- Conditions
- Congenital Aortic Stenosis
- Keywords
- Congenital Aortic Stenosis, Bicuspid Aortic Valve, Left ventricular function, Cardiac imaging, Myocardial tissue characterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Feb 2022 (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.
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy (LVH), myocardial stiffness and myocardial fibrosis.
Detailed description
Congenital aortic stenosis (ConAoS) accounts for 4-8% of all congenital cardiac diagnoses. It is often caused by a bicuspid aortic valve (BAV), which has an estimated prevalence of 0.5-2% in the general population. Patients with ConAoS may remain asymptomatic, but gradual deterioration of the stenosis and the strong association of BAV with aortic dilatation contributes to important morbidity and mortality. The prevalent nature of this heart defect implies an important health problem resulting in hospitalization and (re-) interventions. As it is still largely unknown which markers predict adverse outcome, the aim of this study is to evaluate trends in imaging and biomarkers in this patient population and their relation with clinical outcome.
It is increasingly acknowledged that aortic stenosis is not only a disease of the valve, but also of the left ventricle (LV) and the aorta. In the course of disease progression, pressure overload and ventricular wall stress lead to remodeling of the LV, which eventually leads to left ventricular hypertrophy (LVH) and myocardial fibrosis. Although these processes have been described in patients with aortic stenosis, little is known about the prevalence and prognostic relevance of LVH and myocardial fibrosis in patients with ConAoS, who are often relatively young. Applying upcoming innovative imaging modalities such as high frame rate echocardiography and T1-mapping in patients with ConAoS will increase our knowledge on tissue characterization, which in turn will facilitate identifying patients at high risk for complications and rapid disease progression.
The CAS study is a clinical observational study investigating the effects of ConAoS on the left ventricular function and the prevalence, pattern and expanse of LVH, myocardial stiffness and myocardial fibrosis. Moreover, the prognostic capacity of the presence of these pathological processes will be assessed, correlating findings at baseline to clinical outcome by assessing the occurrence of cardiovascular events and all-cause mortality during 3-year clinical follow-up. The investigators will unravel biomarker and imaging predictors for myocardial dysfunction (systolic and diastolic) with specific attention for male-female differences. This newly gained knowledge will enable the investigators to improve and individualize current treatment protocols and derive novel therapeutic strategies for adult patients with ConAoS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with congenital aortic stenosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult ConAoS patients, who are visiting the outpatient clinic of the Erasmus MC.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients with severe aortic regurgitation
- Presence of any of the following contra-indications for MRI
- Patients known with or previously treated because of aortic coarctation.
- Patients known with genetic syndromes or connective tissue disorders
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
Prevalence of myocardial fibrosis
Time frame: Baseline
Assessed at baseline using cardiovascular magnetic resonance imaging (late gadolinium enhancement (LGE) and T1 mapping pre- and post-contrast)
11 secondary outcomes
Left ventricular function
Time frame: Baseline
Shear wave velocity
Time frame: Baseline
Physical activity in daily life
Time frame: Baseline
Quality of life (SF-36)
Time frame: Baseline
Occurence of ventricular arrhythmias
Time frame: Baseline
Conduction abnormalities on ECG
Time frame: Baseline
All-cause mortality
Time frame: 3 years
Cardiovascular events
Time frame: 3 years
Aortic flow patterns
Time frame: Baseline
Blood biomarkers
Time frame: Baseline
Fear of movement
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Annemien E van den Bosch, MD, PHD principal investigator
Erasmus Medical Center
Alexander Hirsch, MD, PHD principal investigator
Erasmus Medical Center
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 Congenital Aortic Stenosis, run by Erasmus Medical Center at 1 site in Netherlands.
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 0 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Netherlands. 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?
Results are not available in the source record.
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?
Prevalence of myocardial fibrosis (time frame: Baseline). 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 Mar 2024.