French Registry: Late Gadolinium Enhancement in Hypertrop... | NCT07428031

Studies
French Registry: Late Gadolinium Enhancement in Hypertrophic Cardiomyopathy

NCT07428031

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Not yet recruiting

Last Update Posted

Feb 23, 2026Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cardiomyopathy
Hypertrophic Cardiomyopathies

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Estimated

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Mar 1, 2036Estimated

First Submitted Date

Feb 16, 2026

First Submission Date that Met QC Criteria

Feb 16, 2026

First Posted Date

Feb 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2026

Last Update Posted Date

Feb 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to create a registry of patients with hypertrophic cardiomyopathy, a condition characterized by excessive thickening of the heart muscle. This disease can sometimes lead to serious complications. Currently, the prognosis of these patients is mainly determined by clinical and echocardiographic parameters. Detection of myocardial fibrosis using cardiac MRI enables better risk stratification for these patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To build a score using the "LGE granularity" concept for all-cause mortality prediction in HCM patients.	All-cause mortality using the electronic French National Registry of Death (Institut National de la Statistique et des Etudes Economiques, INSEE registry).	From Baseline to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Ability to provide informed consent
HCM diagnosis referred for CMR assessment.

Exclusion Criteria:

Patients unable to provide informed consent,
Patients with a history of ischemic cardiomyopathy or myocarditis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study will include all consecutive patients with a HCM referred for CMR assessment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Théo PEZEL, Dr	Contact	+33 6 68 72 24 89		theo.pezel@aphp.fr

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies
D002312	Cardiomyopathy, Hypertrophic

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular
D001024	Aortic Valve Stenosis

Browse Leaves

Not provided

Browse Branches

Not provided