NCT05252351

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2022Nov 2026

Study Start

First participant enrolled

January 13, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

January 17, 2022

Last Update Submit

March 8, 2024

Conditions

Congenital Aortic Stenosis

Keywords

Congenital Aortic StenosisBicuspid Aortic ValveLeft ventricular functionCardiac imagingMyocardial tissue characterization

Outcome Measures

Primary Outcomes (1)

  • Prevalence of myocardial fibrosis

    Assessed at baseline using cardiovascular magnetic resonance imaging (late gadolinium enhancement (LGE) and T1 mapping pre- and post-contrast)

    Baseline

Secondary Outcomes (11)

  • Left ventricular function

    Baseline

  • Shear wave velocity

    Baseline

  • Physical activity in daily life

    Baseline

  • Quality of life (SF-36)

    Baseline

  • Occurence of ventricular arrhythmias

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Adults with congenital aortic stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of adult ConAoS patients, who are visiting the outpatient clinic of the Erasmus MC.

You may qualify if:

  • Patients with a prior aortic valve replacement (AVR)
  • Patients without a prior AVR and with an aortic jet velocity ≥ 2.5 m/s.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Annemien E van den Bosch, MD, PHD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Alexander Hirsch, MD, PHD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 23, 2022

Study Start

January 13, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

NL(1)