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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Netherlands

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.

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 groups in NCT05252351
Study groupRoleWhat they receive
Adults with congenital aortic stenosisNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Left ventricular function

    This outcome is measured by strain measurements using echocardiography and cardiovascular magnetic resonance imaging (CMR)

    Measured: Baseline

  2. Shear wave velocity

    Shear wave velocity is measured using high frame rate echocardiography

    Measured: Baseline

  3. Physical activity in daily life

    This outcome is measured by the following questionnaire: Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)

    Measured: Baseline

  4. Quality of life (SF-36)

    This outcome is assessed by using the SF-36 questionnaire

    Measured: Baseline

  5. 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

  6. Conduction abnormalities on ECG

    For this outcome the conduction times on ECG will be measured

    Measured: Baseline

  7. All-cause mortality

    Measured: 3 years

  8. 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

  9. Aortic flow patterns

    This outcome is measured using 4D flow CMR

    Measured: Baseline

  10. Blood biomarkers

    Measured: Baseline

  11. 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.

  1. First posted23 Feb 2022
  2. Study start13 Jan 2022
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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)
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

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.

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