Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis

NCT07331116 | Completed

• 1 other identifier: 2017/1068b
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Fibrosis; Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CMR parameters of systolic and diastolic function

  CMR was taken preoperatively, and at 1-year postoperative check-up

Study Arms (2)

Aortic stenosis with biopsy-verified myocardial fibrosis

Periopererative echocardiography

Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Cardiac magnetic resonance imaging

Aortic stenosis without biopsy-verified myocardial fibrosis

Periopererative echocardiography

Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Cardiac magnetic resonance imaging

Interventions

Cardiac magnetic resonance imaging 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.

Aortic stenosis with biopsy-verified myocardial fibrosis; Aortic stenosis without biopsy-verified myocardial fibrosis

Transthoracic echocardiography DIAGNOSTIC_TEST

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

Aortic stenosis with biopsy-verified myocardial fibrosis; Aortic stenosis without biopsy-verified myocardial fibrosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Previous myocardial infarction / coronary disease that can cause fibrosis
• Do not wish to participate in study

Sponsors & Collaborators

• Rikshospitalet University Hospital: collaborator
• Norwegian University of Science and Technology: lead

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

Related Publications (1)

• 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.

  PMID: 24368281 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: January 9, 2026
• Study Start: April 10, 2014
• Primary Completion: February 16, 2021
• Study Completion: March 1, 2021
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

NO (1)