Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:

Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422770
• Other study ID #: 2017/1068
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Fibrosis
• Myocardial Fibrosis

Intervention

Diagnostic Test:
• Echocardiography
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.
• MRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
• Blood 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
ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.
• 6 min walking test
6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.

Locations

Country	Name	City	State
Norway	Department of Circulation and Medical Imaging	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular morbidity and mortality	Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)	1 + 3 year
Secondary	All cause mortality	Mortality in general	3 years
Secondary	Time of first re-hospitalisation	Time of first re-hospitalisation after inclusion	3 years
Secondary	Cardiac systolic function	Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)	1 year.
Secondary	Cardiac diastolic function	Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow	1 year.