Brief Title
Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
Official Title
Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
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
Study Type
Interventional
Primary Outcome
Cardiovascular morbidity and mortality
Secondary Outcome
All cause mortality
Condition
Aortic Valve Stenosis
Intervention
Echocardiography
Study Arms / Comparison Groups
Mild aortic stenosis
Description: 25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
200
Start Date
January 9, 2018
Completion Date
April 2023
Primary Completion Date
April 2023
Eligibility Criteria
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)
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Svend Aakhus, MD PhD, +47 72828072, [email protected]
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT03422770
Organization ID
2017/1068
Responsible Party
Sponsor
Study Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Study Sponsor
Svend Aakhus, MD PhD, Study Director, Norwegian University of Science and Technology
Verification Date
August 2021