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NCT Number: NCT02559726

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

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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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mechanical Hyper-synchronicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography (TEE)

Procedure

Magnetic resonance imaging (MRI) with gadolinium enhancement

Device

Magnetic resonance imaging (MRI) without gadolinium enhancement

Device

3D electrocardiographic mapping (ECM)

Procedure

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

Primary outcomes

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

    Time frame: Day 1

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

Secondary outcomes

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

    Time frame: Day 1

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

    Time frame: Day 1

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

    Time frame: Day 1

  4. 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

  5. Delay between peaks of basal and apical radial displacement in MRI

    Time frame: Day 1

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

    Time frame: Day 1

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

    Time frame: Day 1

  8. Delay between apical and basal peaks circumferential strain in MRI

    Time frame: Day 1

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

    Time frame: Day 1

  10. Twist angle between the base and the apex in MRI

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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.

Acronym: HSYNC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2015
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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