3D Ultrasound Myocardial Mechanical Wave Measurements

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

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-09

Study Completion Date

2027-11-14

Brief Summary

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Primary mitral regurgitation (MR) is a frequent disease that can ultimately lead to heart failure. Primary MR represents the second most prevalent cause of cardiac valve surgery in high income countries. Progressive myocardial fibrosis due to chronic volume overload is recognized as a pathophysiological substrate of altered LV function in primary MR. As fibrosis leads to increased myocardial stiffness, ultrasound mechanical wave propagation measurements within the myocardium could provide important clinical information. Natural mechanical wave velocity (MWV) imaging, using High-frame-rate (HFR) echocardiography has emerged as a promising tool to evaluate myocardial stiffness.

The objective is study is to evaluate the correlation between the LV myocardial stiffness (as assessed by 3D ultrasound myocardial MWV mapping) and myocardial interstitial fibrosis as measured using CMR (myocardial extracellular volume measure)

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Detailed Description

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After being informed about the study. All patients giving written informed consent will undergo in a routine practice:

1. echocardiography (2D/3D),
2. CMR imaging,
3. electrocardiogram 24 hours monitoring,
4. blood sampling including brain natriuretic peptide measurement,
5. symptom-limited combined exercise echocardiography and oxygen uptake measurements

Conditions

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Chronic Primary Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Comprehensive 2D/3D echocardiography

This an observational non interventional study. All patients will have both comprehensive 2D/3D echocardiography (including MWV imaging) and cardiac CMR.

Ultrasound imaging

Intervention Type PROCEDURE

The participants are scanned with an ultrasound scanner

Interventions

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Ultrasound imaging

The participants are scanned with an ultrasound scanner

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered conventional parameters of LV function) (n=10 patients)
* Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) without class I indication of surgery (n=20 patients)
* Mild to moderate primary MR patients as defined by effective regurgitation orifice area ≥ 20mm² and \< 40mm² (n=10 patients)

Exclusion Criteria

* Permanent atrial fibrillation
* Acute primary severe MR
* Secondary MR
* Previous cardiac surgery of any kind
* Other severe left sided valvular disease
* Coronary artery disease
* Congenital cardiac disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No