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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07331116
Acronym
SAS-fibrosis
Enrollment
22
Registered
2026-01-09
Start date
2014-04-10
Completion date
2021-03-01
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Myocardial Fibrosis

Keywords

Myocardial fibrosis, Endomyocardial biopsy, Echocardiography, Aortic stenosis, Diastolic dysfunction

Brief 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.

Interventions

DIAGNOSTIC_TESTTransthoracic echocardiography

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

DIAGNOSTIC_TESTCardiac 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.

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER
Rikshospitalet University Hospital
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Echocardiography parameters of systolic and diastolic functionTime between echocardiography exam and endomyocardial biopsy was kept as short as possible, and not more than one month apart. If no cardiac event had happened in between, echocardiography and biopsy could be regarded as being taken at the same time.Echocardiograhic parameters on structure and function of the heart, as described in guidelines for echocardiography assessment: Basal hypertrophy of interventricular septum, in mm. LV end diastolic mass (preferably from 3D volume of LV) LV end diastolic mass, indexed (preferably from 3D volume of LV) Left ventricular global longitudinal strain (%) Left ventricular ejection fraction, 3D Left ventricular septal strain rate, peak systolic, sample placed in basal septum Grading of diastolic dysfunction (ref EACVI/ASE guidelines) Left atrial strain, reservoir function, biplane Left atrial strain, conduit function , biplane Left atrial strain, (atrial) contraction phase, biplane Severity of aortic stenosis, evaluated by echocardiography (mild, moderate, severe)

Secondary

MeasureTime frameDescription
CMR parameters of systolic and diastolic functionCMR was taken preoperatively, and at 1-year postoperative check-upLeft ventricular (LV) end diastolic volume, CMR LV end systolic volume, CMR LV stroke volume, CMR LV ejection fraction, CMR LV cardiac output, CMR LV cardiac index, CMR Global peak wall thickness, CMR CMR-dreived left ventricular mass, in end-diastole Left atrial volume in left atrial end systole, measured with CMR (left ventricular ED) Left atrial volume in left atrial end diastole, measured with CMR (left ventricular ES) Left atrial ejecton fraction, measured with CMR Global native T1 in myocardium, CMR Global post contrast T1 in myocardium, CMR Global ECV value in myocardium, CMR

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026