NCT06571175

Quantification of Myocardial Fibrosis in Aortis Stenosis

Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Aortic Valve Stenosis
• Myocardial Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	High frame rate echocardiography	Conventional transthoracic echocardiography will be performed, with added 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 2.6) 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. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV)
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 CMRI/echocardiography.

Timeline

• Start date: 2025-01-21
• Primary completion: 2026-03-01
• Completion: 2026-04-15
• First posted: 2024-08-26
• Last updated: 2025-08-07

Locations

1 site across 1 country: Norway