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ENROLLING BY INVITATION
NCT06571175

Quantification of Myocardial Fibrosis in Aortis Stenosis

Sponsor: Norwegian University of Science and Technology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2025-01-21

Completion Date

2026-04-15

Last Updated

2025-08-07

Healthy Volunteers

Not specified

Interventions

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.

Locations (1)

St. Olavs Hosptial

Trondheim, Trøndelag, Norway