NCT03422770

Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Aortic Valve Stenosis
• Myocardial Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiography	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.
DIAGNOSTIC_TEST	MRI	Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
DIAGNOSTIC_TEST	Blood 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.
DIAGNOSTIC_TEST	ECG and Holter-ECG	ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.
DIAGNOSTIC_TEST	6 min walking test	6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Timeline

• Start date: 2018-01-09
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-02-06
• Last updated: 2023-08-16

Locations

1 site across 1 country: Norway