Clinical trial NCT03422770: Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
Official title: Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Myocardial Fibrosis
Keywords: Myocardium
Predictive Value of Tests
Prognosis
Clinical Decision-making
Heart Ventricles
Echocardiography
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Oslo University Hospital
First posted: 2018-02-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
Primary purpose: DIAGNOSTIC

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


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)

Primary outcomes:
measure: Cardiovascular morbidity and mortality
timeFrame: 1 + 3 year
Secondary outcomes:
measure: All cause mortality
timeFrame: 3 years
measure: Time of first re-hospitalisation
timeFrame: 3 years
measure: Cardiac systolic function
timeFrame: 1 year.
measure: Cardiac diastolic function
timeFrame: 1 year.
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Circulation and Medical Imaging
Study officials:
affiliation: Norwegian University of Science and Technology
name: Svend Aakhus, MD PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Brage Høyem Amundsen, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.