NCT07331116

Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis

Correlations Between Biopsy Verified Myocardial Fibrosis and Echocardiography Parameters in Patients With Severe Aortic Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation. The investigators aim to perform a retrospective analysis of these data, to look for correlations between biopsy-verified myocardial fibrosis and echocardiography parameters. The patients also had cardiac magnetic resonance imaging performed, for a non-invasive quantification of myocardial fibrosis.

Detailed description

The primary purpose of the study is to retrospectively compare echocardiography measurements with a myocardial biopsy taken perioperatively in patients with aortic stenosis requiring aortic valve replacement. Echocardiography and endomyocardial biopsy have been performed in close proximity in time. Due to a small sample size and a large number of echocardiography measurements being possible, only a limited number of prespecified comparisons are performed. Cardiac magnetic resonance (CMR) was also performed in patients without contraindication, providing a non-invasive gold standard for diffuse fibrosis and replacement fibrosis. A secondary goal will be to investigate how echocardiography parameters performs compared to CMR in quantifying myocardial fibrosis.

Conditions

• Aortic Valve Stenosis
• Myocardial Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transthoracic echocardiography	Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure
DIAGNOSTIC_TEST	Cardiac magnetic resonance imaging	Cardiac magnetic resonance imaging was taken on selected patients without contraindications. The CMR protocol was changed midway during study inclusions (May 2017), in order to better be able to quantify myocardial fibrosis.

Timeline

• Start date: 2014-04-10
• Primary completion: 2021-02-16
• Completion: 2021-03-01
• First posted: 2026-01-09
• Last updated: 2026-04-17

Locations

1 site across 1 country: Norway