Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing Response

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-22

Study Completion Date

2019-01-19

Brief Summary

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Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract gradient of 30 mmHg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death.

The investigators hypothesize that the electrical approach by dual chamber pacing could improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected patients with a mechanical hyper-synchronicity. The aim of the study is to identify and describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction thanks to innovative multi-imaging approach.

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Detailed Description

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The concept of physiological ventricular desynchrony was described recently with technics of myocardial deformation analysis applied in animal models. Authors confirmed the existence of a time delay in the contraction of the apical walls before basal walls. In O-HCM, the outflow-tract obstruction could be explained by a mechanical hyper-synchronicity between apical and basal walls. This study aims to describe the possible hyper-synchronized contraction in O-HCM and NO-HCM patients unlike the physiological desynchrony observed in healthy volunteers (HV) For this purpose, three imaging tests will be used at baseline: echocardiography (TEE), magnetic resonance imaging (MRI) with gadolinium enhancement only in HCM, and 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan. No follow-up is planned for this study.

Conditions

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Hypertrophic Cardiomyopathy Mechanical Hyper-synchronicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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O-HCM

20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction

Group Type EXPERIMENTAL

Echocardiography (TEE)

Intervention Type PROCEDURE

Magnetic resonance imaging (MRI) with gadolinium enhancement

Intervention Type DEVICE

3D electrocardiographic mapping (ECM)

Intervention Type PROCEDURE

NO-HCM

20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction

Group Type EXPERIMENTAL

Echocardiography (TEE)

Intervention Type PROCEDURE

Magnetic resonance imaging (MRI) with gadolinium enhancement

Intervention Type DEVICE

3D electrocardiographic mapping (ECM)

Intervention Type PROCEDURE

healthy volunteers

20 healthy volunteers

Group Type OTHER

Echocardiography (TEE)

Intervention Type PROCEDURE

Magnetic resonance imaging (MRI) without gadolinium enhancement

Intervention Type DEVICE

3D electrocardiographic mapping (ECM)

Intervention Type PROCEDURE

Interventions

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Echocardiography (TEE)

Intervention Type PROCEDURE

Magnetic resonance imaging (MRI) with gadolinium enhancement

Intervention Type DEVICE

Magnetic resonance imaging (MRI) without gadolinium enhancement

Intervention Type DEVICE

3D electrocardiographic mapping (ECM)

Intervention Type PROCEDURE

Other Intervention Names

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3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan

Eligibility Criteria

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Inclusion Criteria

* HCM: Adults aged more than 18 years with sarcomeric hypertrophic cardiomyopathy under optimal medical therapy, isolated septal hypertrophy, sinus rhythm, exploitable acoustic window. For women of childbearing age, effective contraception and required negative pregnancy test.
* O-HCM : outflow-tract gradient more than 30 mmHg at rest and during exercise
* NO-HCM : outflow-tract gradient less than 30 mmHg at rest and during exercise
* HV: Adults aged more than 18 years, without cardiovascular disease. For women of childbearing age, effective contraception and required negative pregnancy test.