Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Myocardial Fibrosis
• Interventions: Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test

• Registration Number: NCT03422770
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate aortic stenosis	Blood test	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Moderate aortic stenosis	6 min walking test	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Severe aortic stenosis	Echocardiography	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Severe aortic stenosis	MRI	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Mild aortic stenosis	Echocardiography	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Severe aortic stenosis	6 min walking test	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Mild aortic stenosis	MRI	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Mild aortic stenosis	Blood test	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Moderate aortic stenosis	Echocardiography	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Moderate aortic stenosis	ECG and Holter-ECG	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Controls	Blood test	31 subjects, all undergoing echocardiography and blood test and MRI.
Mild aortic stenosis	ECG and Holter-ECG	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Mild aortic stenosis	6 min walking test	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Moderate aortic stenosis	MRI	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Severe aortic stenosis	Blood test	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Controls	Echocardiography	31 subjects, all undergoing echocardiography and blood test and MRI.
Severe aortic stenosis	ECG and Holter-ECG	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Controls	MRI	31 subjects, all undergoing echocardiography and blood test and MRI.

Primary Outcome Measures

Name	Time	Method
Cardiovascular morbidity and mortality	1 + 3 year	Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)

Secondary Outcome Measures

Name	Time	Method
Time of first re-hospitalisation	3 years	Time of first re-hospitalisation after inclusion
All cause mortality	3 years	Mortality in general
Cardiac systolic function	1 year.	Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)
Cardiac diastolic function	1 year.	Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow

Trial Locations

Locations (1)

Department of Circulation and Medical Imaging; 🇳🇴 Trondheim, Norway