Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis (SAS-fibrosis)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Fibrosis; Aortic Valve Stenosis
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography; Diagnostic test: Cardiac magnetic resonance imaging

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study is retrospective. Study participants has been selected among patients on waiting list for aortic valve replacement at Ullevaal Hospital, Oslo, Norway. Ages between 18 and 80 years, with no known other cardiac condition that can cause myocardial fibrosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aortic stenosis with biopsy-verified myocardial fibrosis; Periopererative echocardiography	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.
Aortic stenosis without biopsy-verified myocardial fibrosis; Periopererative echocardiography	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography parameters of systolic and diastolic function	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)	Time 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMR parameters of systolic and diastolic function	Left 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	CMR was taken preoperatively, and at 1-year postoperative check-up

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Rikshospitalet University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2014
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Echocardiography; Aortic stenosis; Diastolic dysfunction; Myocardial fibrosis; Endomyocardial biopsy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 2017/1068b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No