Quantification of Myocardial Fibrosis in Aortis Stenosis (SAS-F-5)

Norwegian University of Science and Technology

Status: Invitation-only

Conditions: Aortic Valve Stenosis; Myocardial Fibrosis

Treatments: Diagnostic Test: High frame rate echocardiography; Diagnostic Test: MRI; Diagnostic Test: 6 min walking test; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG

Study type: Observational

Funder types: Other

Identifiers

NCT06571175

527717

Details and patient eligibility

About

This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.

Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

Full description

High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.

Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.

There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Part of the initial cohort that were included in the baseline study
• Still able to undergo protocolled investigations
• Patients: Mild, moderate or severe AS

Exclusion criteria

• Renal insufficiency
• Previously myocardial infarction (ECG, echocardiogram or hospital record)
• Severe valvular heart disease (except patients)
• Other cardiac disease known to cause myocardial fibrosis
• Severe hypertension
• Other medical conditions deterring protocolled investigation and follow-up
• Other medical conditions affecting 5-years prognosis (cancer, pulmonary disease)
• Severely reduced image-quality (echocardiography and MRI)

Trial design

70 participants in 2 patient groups

Aortic stenosis

Description:

Mild aortic stenosis:25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Moderate aortic stenosis: 25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Severe aortic stenosis: 50 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.

Treatment:

Diagnostic Test: ECG and Holter-ECG

Diagnostic Test: Blood test

Diagnostic Test: 6 min walking test

Diagnostic Test: MRI

Diagnostic Test: High frame rate echocardiography

Controls

Description:

The controls from baseline inclusion will be invited to undergo repeat echocardiography, blood test and CMRI

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: MRI

Diagnostic Test: High frame rate echocardiography