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

Primary Purpose

Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Echocardiography (TEE)

Magnetic resonance imaging (MRI) with gadolinium enhancement

Magnetic resonance imaging (MRI) without gadolinium enhancement

3D electrocardiographic mapping (ECM)

About this trial

This is an interventional basic science trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Exclusion Criteria:

- HV: unusable acoustic window

Sites / Locations

CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

O-HCM

NO-HCM

healthy volunteers

Arm Description

20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction

20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction

20 healthy volunteers

Outcomes

Primary Outcome Measures

Mechanical time delay in contraction between basal and apical walls in TEE and MRI in O-HCM, NO-HCM and healthy volunteers

The main interest variable is the delay value (ms) of the contraction between basal and apical walls measured by TEE and MRI.

Secondary Outcome Measures

Relationship between each mesure with hyper-synchronicity and outflow-tract gradient

Electrical time delay in ECM between basal and apical walls and relationship with hyper-synchronicity and outflow tract gradient.

Mechanical time delay between septal and lateral walls in MRI and TEE.

Evolution of mechanical time delay between basal and apical walls at rest and exercise in O-HCM and NO-HCM and relationship with outflow-tract gradient.

Delay between peaks of basal and apical radial displacement in MRI

Delay between the beginning of the apical and basal radial displacement in MRI

Apical-basal phase on a phase analysis of the radial displacement data in MRI

Delay between apical and basal peaks circumferential strain in MRI

Delay between the beginning of the apical and basal circumferential deformation in MRI

Twist angle between the base and the apex in MRI

Full Information

NCT ID

NCT02559726

First Posted

June 26, 2015

Last Updated

February 8, 2022

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT02559726

Brief Title

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

Acronym

HSYNC

Official Title

Identification and Quantification of a Mechanical Hyper-synchronicity State in Hypertrophic Cardiomyopathy (HCM) With Left Outflow-tract Obstruction and Description of Its Electrical and Electro-mechanical Characteristics Thanks to an Innovative Multi-imaging Approach to Predict a Positive Response to Dual Chamber Pacing. The Hsync Study.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

June 22, 2015 (Actual)

Primary Completion Date

January 19, 2019 (Actual)

Study Completion Date

January 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity

Keywords

Hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

O-HCM

Arm Type

Experimental

Arm Description

20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction

Arm Title

NO-HCM

Arm Type

Experimental

Arm Description

20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction

Arm Title

healthy volunteers

Arm Type

Other

Arm Description

20 healthy volunteers

Intervention Type

Procedure

Intervention Name(s)

Echocardiography (TEE)

Intervention Type

Device

Intervention Name(s)

Magnetic resonance imaging (MRI) with gadolinium enhancement

Intervention Type

Device

Intervention Name(s)

Magnetic resonance imaging (MRI) without gadolinium enhancement

Intervention Type

Procedure

Intervention Name(s)

3D electrocardiographic mapping (ECM)

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Mechanical time delay in contraction between basal and apical walls in TEE and MRI in O-HCM, NO-HCM and healthy volunteers

Description

The main interest variable is the delay value (ms) of the contraction between basal and apical walls measured by TEE and MRI.

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Relationship between each mesure with hyper-synchronicity and outflow-tract gradient

Time Frame

Day 1

Title

Electrical time delay in ECM between basal and apical walls and relationship with hyper-synchronicity and outflow tract gradient.

Time Frame

Day 1

Title

Mechanical time delay between septal and lateral walls in MRI and TEE.

Time Frame

Day 1

Title

Evolution of mechanical time delay between basal and apical walls at rest and exercise in O-HCM and NO-HCM and relationship with outflow-tract gradient.

Time Frame

Day 1

Title

Delay between peaks of basal and apical radial displacement in MRI

Time Frame

Day 1

Title

Delay between the beginning of the apical and basal radial displacement in MRI

Time Frame

Day 1

Title

Apical-basal phase on a phase analysis of the radial displacement data in MRI

Time Frame

Day 1

Title

Delay between apical and basal peaks circumferential strain in MRI

Time Frame

Day 1

Title

Delay between the beginning of the apical and basal circumferential deformation in MRI

Time Frame

Day 1

Title

Twist angle between the base and the apex in MRI

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Exclusion Criteria: - HV: unusable acoustic window

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire CORNOLLE, Dr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Bordeaux

City

Bordeaux

ZIP/Postal Code

33000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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