NCT02559726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2019

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

June 26, 2015

Last Update Submit

February 8, 2022

Conditions

Hypertrophic CardiomyopathyMechanical Hyper-synchronicity

Keywords

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

Outcome Measures

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

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

    Day 1

Secondary Outcomes (10)

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

    Day 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 MRI

    Day 1

  • +5 more secondary outcomes

Study Arms (3)

O-HCM

EXPERIMENTAL

20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction

Procedure: Echocardiography (TEE)Device: Magnetic resonance imaging (MRI) with gadolinium enhancementProcedure: 3D electrocardiographic mapping (ECM)

NO-HCM

EXPERIMENTAL

20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction

Procedure: Echocardiography (TEE)Device: Magnetic resonance imaging (MRI) with gadolinium enhancementProcedure: 3D electrocardiographic mapping (ECM)

healthy volunteers

OTHER

20 healthy volunteers

Procedure: Echocardiography (TEE)Device: Magnetic resonance imaging (MRI) without gadolinium enhancementProcedure: 3D electrocardiographic mapping (ECM)

Interventions

Echocardiography (TEE)PROCEDURE
NO-HCMO-HCMhealthy volunteers
Magnetic resonance imaging (MRI) with gadolinium enhancementDEVICE
NO-HCMO-HCM
Magnetic resonance imaging (MRI) without gadolinium enhancementDEVICE
healthy volunteers
3D electrocardiographic mapping (ECM)PROCEDURE
Also known as: 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan
NO-HCMO-HCMhealthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- HV: unusable acoustic window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

  • Reant P, Bonnet G, Dube F, Massie C, Reynaud A, Michaud M, Duchateau J, Lafitte S. Hypersynchrony in sarcomeric hypertrophic cardiomyopathy: description and mechanistic approach using multimodal electro-mechanical non-invasive cartography (HSYNC study). Front Cardiovasc Med. 2024 Jun 7;11:1359657. doi: 10.3389/fcvm.2024.1359657. eCollection 2024.

    PMID: 38911519DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Claire CORNOLLE, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

September 24, 2015

Study Start

June 22, 2015

Primary Completion

January 19, 2019

Study Completion

January 19, 2019

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

FR(1)