Quantification of Myocardial Fibrosis in Aortis Stenosis

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.

Conditions

• Aortic Valve Stenosis
• Myocardial Fibrosis

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.

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MRI

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

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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.

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Brage H: Amundsen, MD, PhD · Norwegian University of Science and Technology (NTNU)

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-21

Primary Completion

2026-03-01

Completion

2026-04-15

Countries

• Norway

Study Locations