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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)

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ClinicalTrials.gov Identifier: NCT02559726
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Mechanical Hyper-synchronicity Procedure: Echocardiography (TEE) Device: Magnetic resonance imaging (MRI) with gadolinium enhancement Device: Magnetic resonance imaging (MRI) without gadolinium enhancement Procedure: 3D electrocardiographic mapping (ECM) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : June 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: O-HCM
20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction
 Procedure: Echocardiography (TEE)
Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
Procedure: 3D electrocardiographic mapping (ECM)
Other Name: 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan
Experimental: NO-HCM
20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction
 Procedure: Echocardiography (TEE)
Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
Procedure: 3D electrocardiographic mapping (ECM)
Other Name: 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan
healthy volunteers
20 healthy volunteers
 Procedure: Echocardiography (TEE)
Device: Magnetic resonance imaging (MRI) without gadolinium enhancement
Procedure: 3D electrocardiographic mapping (ECM)
Other Name: 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559726


Contacts
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Contact: Claire CORNOLLE, Dr claire.cornolle@chu-bordeaux.fr
Contact: Christel DUPRAT christel.duprat@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Claire Cornolle, Dr       claire.cornolle@chu-bordeaux.fr   
Contact: Christel Duprat       christel.duprat@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Claire CORNOLLE, Dr University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02559726     History of Changes
Other Study ID Numbers: CHUBX 2014/06
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Bordeaux:
Hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases