French Hypertrophic Cardiomyopathy Observatory (REMY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by French Cardiology Society
Sponsor:
Information provided by (Responsible Party):
Hagege Albert, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01091480
First received: March 8, 2010
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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)


Condition
Hypertrophic Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: French Hypertrophic Cardiomyopathy Observatory

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Diagnostic methods [ Time Frame: 0 day ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with HCM
Patients ≥ 15 years with HCM(sarcomere of origin or not) defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients ≥ 15 years old with HCM (sarcomere of origin or not) defined by an ultrasound thickness of the left ventricle ≥ 13 mm if familial or ≥ 15 mm if sporadic

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091480

Contacts
Contact: Albert Hagege 33(0)156092897 albert.hagege@egp.ap-hop-paris.fr

Locations
France
European Georges Pompidou Hospital Recruiting
Paris, France, 75015
Contact: Albert Hagege    33(0)156093683    albert.hagege@egp.ap-hop-paris.fr   
Contact: Geneviève Mulak    33(0)143223333    secretariat.registre@sfcardio.fr   
Principal Investigator: Albert Hagege         
Sponsors and Collaborators
French Cardiology Society
  More Information

No publications provided

Responsible Party: Hagege Albert, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01091480     History of Changes
Other Study ID Numbers: 09273
Study First Received: March 8, 2010
Last Updated: July 8, 2014
Health Authority: France : National Commission on Informatics and Freedoms

Keywords provided by French Cardiology Society:
Hypertrophic cardiomyopathy
Observatory
LVH

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014