Clinical trial NCT06571175: Quantification of Myocardial Fibrosis in Aortis Stenosis
Official title: Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Stenosis
Myocardial Fibrosis
Keywords: High frame rate echocardiography
Heart failure
Aortic stenosis
Cardiac MRI
Prognosis
Quantification of severity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Oslo University Hospital
First posted: 2024-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients: Mild, moderate, or severe aortic valve stenosis. A subset of the patients will have undergone aortic valve replacement since inclusion.

Controls: Healthy with no valve disease, or other cardiac disease known to cause myocardial fibrosis

Brief summary: This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.

Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

Detailed description: High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.

Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.

There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.

Eligibility criteria: Inclusion Criteria:

* Part of the initial cohort that were included in the baseline study
* Still 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-years prognosis (cancer, pulmonary disease)
* Severely reduced image-quality (echocardiography and MRI)

Primary outcomes:
measure: Cardiovascular morbidity
timeFrame: 5 year
measure: Cardiovascular mortality
timeFrame: 5 year
Secondary outcomes:
measure: All cause mortality
timeFrame: 5 years
measure: Time of first re-hospitalization
timeFrame: 5 years
measure: Cardiac systolic function
timeFrame: 5 years
measure: Cardiac diastolic function (1 of 5)
timeFrame: 5 years
measure: Cardiac diastolic function (2 of 5)
timeFrame: 5 years
measure: Cardiac diastolic function (3 of 5)
timeFrame: 5 years
measure: Cardiac diastolic function (4 of 5)
timeFrame: 5 years
measure: Cardiac diastolic function (5 of 5)
timeFrame: 5 years
measure: Velocity of natural mechanical waves propagating through the myocardium
timeFrame: 5 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hosptial
state: Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology (NTNU)
name: Brage H: Amundsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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.
citation: M. Mohajery, S. Salles, T. Espeland, S. Fadnes and L. Lovstakken,
citation: Espeland T, Wigen MS, Dalen H, Berg EAR, Hammer TA, Salles S, Lovstakken L, Amundsen BH, Aakhus S. Mechanical Wave Velocities in Left Ventricular Walls in Healthy Subjects and Patients With Aortic Stenosis. JACC Cardiovasc Imaging. 2024 Feb;17(2):111-124. doi: 10.1016/j.jcmg.2023.07.009. Epub 2023 Sep 6.