Quantification of Myocardial Fibrosis in Aortis Stenosis

NCT06571175 | Enrolling By Invitation

• 1 other identifier: 527717
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis. Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

Conditions

Aortic Valve Stenosis; Myocardial Fibrosis

Keywords

High frame rate echocardiography; Heart failure; Aortic stenosis; Cardiac MRI; Prognosis; Quantification of severity

Outcome Measures

Primary Outcomes (2)

• Cardiovascular morbidity

  Admissions with heart failure

  5 year

• Cardiovascular mortality

  Death caused by cardiac disease

  5 year

Secondary Outcomes (9)

• All cause mortality

  5 years

• Time of first re-hospitalization

  5 years

• Cardiac systolic function

  5 years

• Cardiac diastolic function (1 of 5)

  5 years

• Cardiac diastolic function (2 of 5)

  5 years

Study Arms (2)

Aortic stenosis

Mild aortic stenosis:25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Moderate aortic stenosis: 25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Severe aortic stenosis: 50 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.

Diagnostic Test: High frame rate echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test

Controls

The controls from baseline inclusion will be invited to undergo repeat echocardiography, blood test and CMRI

Diagnostic Test: High frame rate echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test

Interventions

High frame rate echocardiography DIAGNOSTIC_TEST

Conventional transthoracic echocardiography will be performed, with added 3D-imaging and acquisitions with high frame rate. The data from these patients will be anonymized and transferred for post-hoc analysis in dedicated computer software (GE Vingmed, EchoPac 2.6) and in validated machine learning algorithms.

Also known as: GE Vingmed ultrasound scanner E95, 2017

Aortic stenosis; Controls

MRI DIAGNOSTIC_TEST

Cardiac MRI will be performed. In all patients without contraindications, a gadolinium-based contrast agent will be given.

Also known as: Cardiac magnetic resonance imaging (CMRI)

Aortic stenosis; Controls

Blood test DIAGNOSTIC_TEST

Conventional brachial venous blood samples will be drawn. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV)

Aortic stenosis; Controls

ECG and Holter-ECG DIAGNOSTIC_TEST

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

Aortic stenosis

6 min walking test DIAGNOSTIC_TEST

6 MWT will be performed, and the findings will be related to findings from CMRI/echocardiography.

Aortic stenosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients: Mild, moderate, or severe aortic valve stenosis. A subset of the patients will have undergone aortic valve replacement since inclusion. Controls: Healthy with no valve disease, or other cardiac disease known to cause myocardial fibrosis

You may qualify if:

• Part of the initial cohort that were included in the baseline study
• Still able to undergo protocolled investigations
• Patients: Mild, moderate or severe AS

You may not qualify if:

• Renal insufficiency
• Previously myocardial infarction (ECG, echocardiogram or hospital record)
• Severe valvular heart disease (except patients)
• Other cardiac disease known to cause myocardial fibrosis
• Severe hypertension
• Other medical conditions deterring protocolled investigation and follow-up
• Other medical conditions affecting 5-years prognosis (cancer, pulmonary disease)
• Severely reduced image-quality (echocardiography and MRI)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

St. Olavs Hosptial

Trondheim, Trøndelag, 7030, Norway

Location

Related Publications (3)

• Salles S, Espeland T, Molares A, Aase SA, Hammer TA, Stoylen A, Aakhus S, Lovstakken L, Torp H. 3D Myocardial Mechanical Wave Measurements: Toward In Vivo 3D Myocardial Elasticity Mapping. JACC Cardiovasc Imaging. 2021 Aug;14(8):1495-1505. doi: 10.1016/j.jcmg.2020.05.037. Epub 2020 Aug 26.

  PMID: 32861651 BACKGROUND

• M. Mohajery, S. Salles, T. Espeland, S. Fadnes and L. Lovstakken,

  BACKGROUND

• Espeland T, Wigen MS, Dalen H, Berg EAR, Hammer TA, Salles S, Lovstakken L, Amundsen BH, Aakhus S. Mechanical Wave Velocities in Left Ventricular Walls in Healthy Subjects and Patients With Aortic Stenosis. JACC Cardiovasc Imaging. 2024 Feb;17(2):111-124. doi: 10.1016/j.jcmg.2023.07.009. Epub 2023 Sep 6.

  PMID: 37676209 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Failure

Interventions

Hematologic Tests; Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Brage H: Amundsen, MD, PhD

  Norwegian University of Science and Technology (NTNU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 26, 2024
• Study Start: January 21, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

NO (1)