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NCT Number: NCT01091480

French Hypertrophic Cardiomyopathy Observatory

Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.

The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Georges Pompidou Hospital

Paris, 75015, France

Location status: Recruiting

Location contact

Albert Hagege

CONTACT

[email protected]

33(0)156093683

Albert Hagege

PRINCIPAL_INVESTIGATOR

About this study

This both retrospective and prospective study is proposed to cardiology services 50 hospitals in France. A cardiologist referral is designated for each facility.

The following data will be collected by the physician during the initial hospitalization

  • Demographics
  • Geographic origin of patient
  • Clinical data: criteria for inclusion and non-inclusion data HCM general, Doppler ultrasound, personal history, family history
  • Reviews made: non-organic, biological
  • Family Survey,
  • Treatments: Medical, Electrical, invasive
  • Data from hospital

The follow-up to 18 months, 3 years and 5 years will be conducted by clinical-research-technicians of the French Society of Cardiology, an application will be made to municipalities of birth and mail a letter to physicians and patients.

The following data will be collected:

  • Vital status
  • Data from hospital
  • Reviews made: non-organic, biological
  • Treatments: Medical, Electrical, invasive

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 15 years old
  • Patient with HCM defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

Exclusion criteria

  • Expressed refusal to participate in the study
  • Significant aortic stenosis (<1 cm ²)

Treatment and study plan

Primary outcomes

  1. Event-free survival

    Time frame: 3 years

Secondary outcomes

  1. Diagnostic methods

    Time frame: 0 day

    Define the profile of patients with HCM in France, diagnostic methods, evaluation (diagnostic investigation and family) and therapeutic. Who are the patients CMH France? (rules discovery, clinical presentation) and how are assumed the HCM in France? (examinations, hospitalizations, treatments, procedures for the family survey).

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Hagege

CONTACT

[email protected]

33(0)156092897

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: REMY

Important dates

Study start
2010
Primary completion
2023
Study completion
2028
First posted
Mar 24, 2010
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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