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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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02559726
Acronym
HSYNC
Enrollment
60
Registered
2015-09-24
Start date
2015-06-22
Completion date
2019-01-19
Last updated
2022-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity

Keywords

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

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.

Interventions

PROCEDUREEchocardiography (TEE)
DEVICEMagnetic resonance imaging (MRI) with gadolinium enhancement
DEVICEMagnetic resonance imaging (MRI) without gadolinium enhancement
PROCEDURE3D electrocardiographic mapping (ECM)

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical time delay in contraction between basal and apical walls in TEE and MRI in O-HCM, NO-HCM and healthy volunteersDay 1The main interest variable is the delay value (ms) of the contraction between basal and apical walls measured by TEE and MRI.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026