Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

Norwegian University of Science and Technology

Status: Completed

Conditions: Aortic Valve Stenosis; Myocardial Fibrosis

Treatments: Diagnostic Test: 6 min walking test; Diagnostic Test: Echocardiography; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03422770

2017/1068

Details and patient eligibility

About

This study is part of a research project in which new ultrasound-based techniques will be examined to improve clinical decision making for patients with aortic stenosis. These patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based parameters will be developed for the assessment of the amounts of myocardial fibrosis, especially in the left ventricle. Then it will be examined whether these parameters can predict the patients magnitude of fibrosis and check for association with the patients prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The new echocardiographic techniques and parameters are expected to provide new insights in the interplay between aortic stenosis and left ventricular function, and to ultimately improve the care for patients with aortic stenosis.

The present study's objectives are:

• Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis compared with a healthy population.
• Evaluate the patients outcome after one and three year of follow-up

Enrollment: 132 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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-yrs prognosis (cancer, pulmonary disease)
• Severely reduced image-quality (echocardiography and MRI)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 4 patient groups

Mild aortic stenosis

Other group

Description:

25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: 6 min walking test

Diagnostic Test: Blood test

Diagnostic Test: Echocardiography

Diagnostic Test: ECG and Holter-ECG

Moderate aortic stenosis

Other group

Description:

25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: 6 min walking test

Diagnostic Test: Blood test

Diagnostic Test: Echocardiography

Diagnostic Test: ECG and Holter-ECG

Severe aortic stenosis

Other group

Description:

50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: 6 min walking test

Diagnostic Test: Blood test

Diagnostic Test: Echocardiography

Diagnostic Test: ECG and Holter-ECG

Controls

Other group

Description:

31 subjects, all undergoing echocardiography and blood test and MRI.

Treatment:

Diagnostic Test: MRI

Diagnostic Test: Blood test

Diagnostic Test: Echocardiography