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Completed

NCT Number: NCT03422770

Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

This study is part of a research project in which new ultrasound-based techniques will be examined to improve clinical decision making for patients with aortic stenosis. These patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based parameters will be developed for the assessment of the amounts of myocardial fibrosis, especially in the left ventricle. Then it will be examined whether these parameters can predict the patients magnitude of fibrosis and check for association with the patients prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The new echocardiographic techniques and parameters are expected to provide new insights in the interplay between aortic stenosis and left ventricular function, and to ultimately improve the care for patients with aortic stenosis.

The present study's objectives are:

* Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis compared with a healthy population. * Evaluate the patients outcome after one and three year of follow-up

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Myocardial Fibrosis Ventricular Outflow Obstruction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Circulation and Medical Imaging

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to undergo protocolled investigations
  • Patients: Mild, moderate or severe AS

Exclusion criteria

  • 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-yrs prognosis (cancer, pulmonary disease)
  • Severely reduced image-quality (echocardiography and MRI)

Treatment and study plan

Echocardiography

Diagnostic Test

Conventional transthoracic echocardiography will be performed, in addition 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 2.0) and in validated machine learning algorithms.

Other names: GE Vingmed ultrasound scanner e95, 2017

MRI

Diagnostic Test

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

Other names: Magnetic resonance imaging

Blood test

Diagnostic Test

Conventional brachial venous blood samples will be drawn. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.

ECG and Holter-ECG

Diagnostic Test

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

6 min walking test

Diagnostic Test

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

Primary outcomes

  1. Cardiovascular morbidity and mortality

    Time frame: 1 + 3 year

    Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)

Secondary outcomes

  1. All cause mortality

    Time frame: 3 years

    Mortality in general

  2. Time of first re-hospitalisation

    Time frame: 3 years

    Time of first re-hospitalisation after inclusion

  3. Cardiac systolic function

    Time frame: 1 year.

    Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)

  4. Cardiac diastolic function

    Time frame: 1 year.

    Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2018
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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