Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

Norwegian University of Science and Technology132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

132

Conditions

Aortic Valve Stenosis Myocardial Fibrosis

Interventions

EchocardiographyDIAGNOSTIC_TEST

Conventional transthoracic echocardiography will be performed, in addition 3D-imaging and acquisitions with high frame rate. The data from these patients will be anonymized and transferred for post-hoc analysis in dedicated computer software (GE Vingmed, EchoPac 2.0) and in validated machine learning algorithms.

MRIDIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.

Blood testDIAGNOSTIC_TEST

Conventional brachial venous blood samples will be drawn. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.

ECG and Holter-ECGDIAGNOSTIC_TEST

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

6 min walking testDIAGNOSTIC_TEST

6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Cardiovascular morbidity and mortality

Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)

Time frame: 1 + 3 year

Secondary Outcomes

All cause mortality

Mortality in general

Time frame: 3 years

Time of first re-hospitalisation

Time of first re-hospitalisation after inclusion

Time frame: 3 years

Cardiac systolic function

Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)

Time frame: 1 year.

Cardiac diastolic function

Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow