Quantification of Myocardial Fibrosis in Aortis Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis

NCT07331116

Aortic Valve Stenosis Myocardial Fibrosis

COMPLETED

Assessment of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.

NCT01739075

Myocardial Ischemia

COMPLETED

Fibrosis in Chronic and Delayed Myocardial Infarction

NCT05756608

Aortic Stenosis Chemotherapy Induced Systolic Dysfunction Carcinoid Syndrome

RECRUITING

Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.

NCT02018835

Dilated Cardiomyopathy

COMPLETED NA

Non-invasive Diagnosis of Coronary Artery Stenoses by Doppler Echocardiography

NCT00281346

Stable Angina Pectoris Unstable Angina Pectoris Acute Myocardial Infarction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis Myocardial Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aortic stenosis

Mild aortic stenosis:25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.

Moderate aortic stenosis: 25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.

Severe aortic stenosis: 50 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.