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

Hypertrophic Cardiomyopathy Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559726
• Other study ID #: CHUBX 2014/06
• Status: Completed
• Phase: N/A
• Start date: June 22, 2015
• Est. completion date: January 19, 2019

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 19, 2019
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Mechanical Hyper-synchronicity

Intervention

Procedure:
• Echocardiography (TEE)

Device:
• Magnetic resonance imaging (MRI) with gadolinium enhancement

• Magnetic resonance imaging (MRI) without gadolinium enhancement

Procedure:
• 3D electrocardiographic mapping (ECM)

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Relationship between each mesure with hyper-synchronicity and outflow-tract gradient		Day 1
Secondary	Electrical time delay in ECM between basal and apical walls and relationship with hyper-synchronicity and outflow tract gradient.		Day 1
Secondary	Mechanical time delay between septal and lateral walls in MRI and TEE.		Day 1
Secondary	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.		Day 1
Secondary	Delay between peaks of basal and apical radial displacement in MRI		Day 1
Secondary	Delay between the beginning of the apical and basal radial displacement in MRI		Day 1
Secondary	Apical-basal phase on a phase analysis of the radial displacement data in MRI		Day 1
Secondary	Delay between apical and basal peaks circumferential strain in MRI		Day 1
Secondary	Delay between the beginning of the apical and basal circumferential deformation in MRI		Day 1
Secondary	Twist angle between the base and the apex in MRI		Day 1