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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

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02559726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • Relationship between each mesure with hyper-synchronicity and outflow-tract gradient [ Time Frame: Day 1 ]
  • Electrical time delay in ECM between basal and apical walls and relationship with hyper-synchronicity and outflow tract gradient. [ Time Frame: Day 1 ]
  • Mechanical time delay between septal and lateral walls in MRI and TEE. [ Time Frame: 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. [ Time Frame: Day 1 ]
  • Delay between peaks of basal and apical radial displacement in MRI [ Time Frame: Day 1 ]
  • Delay between the beginning of the apical and basal radial displacement in MRI [ Time Frame: Day 1 ]
  • Apical-basal phase on a phase analysis of the radial displacement data in MRI [ Time Frame: Day 1 ]
  • Delay between apical and basal peaks circumferential strain in MRI [ Time Frame: Day 1 ]
  • Delay between the beginning of the apical and basal circumferential deformation in MRI [ Time Frame: Day 1 ]
  • Twist angle between the base and the apex in MRI [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing Response
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hypertrophic Cardiomyopathy
  • Mechanical Hyper-synchronicity
Intervention  ICMJE
  • Procedure: Echocardiography (TEE)
  • Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
  • 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
Study Arms  ICMJE
  • Experimental: O-HCM
    20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction
    Interventions:
    • Procedure: Echocardiography (TEE)
    • Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
    • Procedure: 3D electrocardiographic mapping (ECM)
  • Experimental: NO-HCM
    20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction
    Interventions:
    • Procedure: Echocardiography (TEE)
    • Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
    • Procedure: 3D electrocardiographic mapping (ECM)
  • healthy volunteers
    20 healthy volunteers
    Interventions:
    • Procedure: Echocardiography (TEE)
    • Device: Magnetic resonance imaging (MRI) without gadolinium enhancement
    • Procedure: 3D electrocardiographic mapping (ECM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02559726
Other Study ID Numbers  ICMJE CHUBX 2014/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire CORNOLLE, Dr University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP