Hypertrophic CardiomyopathyHSYNCNCT02559726

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

A study testing Echocardiography (TEE), Magnetic resonance imaging (MRI) with gadolinium enhancement and Magnetic resonance imaging (MRI) without gadolinium enhancement in people with Hypertrophic Cardiomyopathy and Mechanical Hyper-synchronicity, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity
What is being tested?: Echocardiography (TEE), Magnetic resonance imaging (MRI) with gadolinium enhancement and Magnetic resonance imaging (MRI) without gadolinium enhancement
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteFrance
Study dates: 22 Jun 2015to 19 Jan 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

HV: unusable acoustic window

Trial locations and contacts

1 site in 1 country.

France1 site

CHU de Bordeaux
Bordeaux, 33000

Other trials in France

About this study

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.

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.

Read the 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.

Conditions: Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity
Being tested: Echocardiography (TEE), Magnetic resonance imaging (MRI) with gadolinium enhancement, Magnetic resonance imaging (MRI) without gadolinium enhancement, 3D electrocardiographic mapping (ECM)
Keywords: Hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing
Medical subject headings: Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Echocardiography (TEE)Procedure or surgery
Magnetic resonance imaging (MRI) with gadolinium enhancementDevice
Magnetic resonance imaging (MRI) without gadolinium enhancementDevice
3D electrocardiographic mapping (ECM)Procedure or surgery
Also called 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan

Study groups in NCT02559726
Study group	Role	What they receive
O-HCM	Experimental	20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction Receives: Procedure: Echocardiography (TEE); Device: Magnetic resonance imaging (MRI) with gadolinium enhancement; Procedure: 3D electrocardiographic mapping (ECM)
NO-HCM	Experimental	20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction Receives: Procedure: Echocardiography (TEE); Device: Magnetic resonance imaging (MRI) with gadolinium enhancement; Procedure: 3D electrocardiographic mapping (ECM)
healthy volunteers	Other	20 healthy volunteers Receives: Procedure: Echocardiography (TEE); Device: Magnetic resonance imaging (MRI) without gadolinium enhancement; Procedure: 3D electrocardiographic mapping (ECM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Secondary outcomes (10)

Relationship between each mesure with hyper-synchronicity and outflow-tract gradient
Measured: Day 1
Electrical time delay in ECM between basal and apical walls and relationship with hyper-synchronicity and outflow tract gradient.
Measured: Day 1
Mechanical time delay between septal and lateral walls in MRI and TEE.
Measured: 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.
Measured: Day 1
Delay between peaks of basal and apical radial displacement in MRI
Measured: Day 1
Delay between the beginning of the apical and basal radial displacement in MRI
Measured: Day 1
Apical-basal phase on a phase analysis of the radial displacement data in MRI
Measured: Day 1
Delay between apical and basal peaks circumferential strain in MRI
Measured: Day 1
Delay between the beginning of the apical and basal circumferential deformation in MRI
Measured: Day 1
Twist angle between the base and the apex in MRI
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201519 Jan 2019

First posted24 Sep 2015 (estimated)
Study start22 Jun 2015
Primary completion19 Jan 2019
Study completion19 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02559726
Sponsor's protocol ID: CHUBX 2014/06
Acronym: HSYNC
Status last verified: Feb 2022
First submitted: 26 Jun 2015
Last updated: 14 Feb 2022
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 38911519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertrophic Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02559726
Acronym / sponsor ID: HSYNC / CHUBX 2014/06
Conditions: Hypertrophic Cardiomyopathy, Mechanical Hyper-synchronicity
Keywords: Hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Hospital, BordeauxUniversity, hospital or other
Study start: 22 Jun 2015 (actual)
Primary completion: 19 Jan 2019 (actual)
Study completion: 19 Jan 2019 (actual)
First posted: 24 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
O-HCM	Experimental	Procedure: Echocardiography (TEE), Device: Magnetic resonance imaging (MRI) with gadolinium enhancement, Procedure: 3D electrocardiographic mapping (ECM)20 patients with Hypertrophic Cardiomyopathy with outflow-tract obstruction
NO-HCM	Experimental	Procedure: Echocardiography (TEE), Device: Magnetic resonance imaging (MRI) with gadolinium enhancement, Procedure: 3D electrocardiographic mapping (ECM)20 patients with Hypertrophic Cardiomyopathy without outflow-tract obstruction
healthy volunteers	Other	Procedure: Echocardiography (TEE), Device: Magnetic resonance imaging (MRI) without gadolinium enhancement, Procedure: 3D electrocardiographic mapping (ECM)20 healthy volunteers

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

HV: unusable acoustic window

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Echocardiography (TEE)	Procedure or surgery	NO-HCM, O-HCM, healthy volunteers
Magnetic resonance imaging (MRI) with gadolinium enhancement	Device	NO-HCM, O-HCM
Magnetic resonance imaging (MRI) without gadolinium enhancement	Device	healthy volunteers
3D electrocardiographic mapping (ECM)Also: 3-dimensional electrocardiographic mapping (ECM) combined with computed tomography-scan	Procedure or surgery	NO-HCM, O-HCM, healthy volunteers

Primary outcome

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.

10 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Derived from this study: PubMed 38911519Reant 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.

Related trials for Hypertrophic Cardiomyopathy

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
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Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claire CORNOLLE, Dr principal investigator

University Hospital, Bordeaux

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.