Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis

NCT ID: NCT07331116

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-10

Study Completion Date

2021-03-01

Brief Summary

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Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation. We 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

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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

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Aortic Valve Stenosis Myocardial Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aortic stenosis with biopsy-verified myocardial fibrosis

Periopererative echocardiography

Cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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.

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure

Aortic stenosis without biopsy-verified myocardial fibrosis

Periopererative echocardiography

Cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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.

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiography

Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Planned for aortic valve replacement for symptomatic, severe aortic stenosis

Exclusion Criteria

* Previous myocardial infarction / coronary disease that can cause fibrosis
* Do not wish to participate in study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rikshospitalet University Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Norwegian University of Science and Technology

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Almaas VM, Haugaa KH, Strom EH, Scott H, Smith HJ, Dahl CP, Geiran OR, Endresen K, Aakhus S, Amlie JP, Edvardsen T. Noninvasive assessment of myocardial fibrosis in patients with obstructive hypertrophic cardiomyopathy. Heart. 2014 Apr;100(8):631-8. doi: 10.1136/heartjnl-2013-304923. Epub 2013 Dec 24.

Reference Type BACKGROUND
PMID: 24368281 (View on PubMed)

Other Identifiers

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2017/1068b

Identifier Type: -

Identifier Source: org_study_id

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