World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 4 July 2016
Main ID:  NCT02559726
Date of registration: 26/06/2015
Prospective Registration: Yes
Primary sponsor: University Hospital, Bordeaux
Public title: Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing Response HSYNC
Scientific 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.
Date of first enrolment: June 2015
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02559726
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Claire Cornolle, Dr
Address: 
Telephone:
Email: claire.cornolle@chu-bordeaux.fr
Affiliation: 
Name:     Claire CORNOLLE, Dr
Address: 
Telephone:
Email: claire.cornolle@chu-bordeaux.fr
Affiliation: 
Name:     Claire CORNOLLE, Dr
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Bordeaux
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Mechanical Hyper-synchronicity
Intervention(s)
Device: Magnetic resonance imaging (MRI) with gadolinium enhancement
Device: Magnetic resonance imaging (MRI) without gadolinium enhancement
Procedure: 3D electrocardiographic mapping (ECM)
Procedure: Echocardiography (TEE)
Primary Outcome(s)
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]
Secondary Outcome(s)
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 peaks of basal and apical radial displacement in MRI [Time Frame: Day 1]
Delay between the beginning of the apical and basal circumferential deformation in MRI [Time Frame: Day 1]
Delay between the beginning of the apical and basal radial displacement in MRI [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]
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]
Mechanical time delay between septal and lateral walls in MRI and TEE. [Time Frame: Day 1]
Relationship between each mesure with hyper-synchronicity and outflow-tract gradient [Time Frame: Day 1]
Twist angle between the base and the apex in MRI [Time Frame: Day 1]
Secondary ID(s)
CHUBX 2014/06
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history