French Hypertrophic Cardiomyopathy Observatory

NCT01091480 | Recruiting

• 1 other identifier: 09273
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathy; Observatory; LVH

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  3 years

Secondary Outcomes (1)

• Diagnostic methods

  0 day

Study Arms (1)

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

European Georges Pompidou Hospital

Paris, 75015, France

RECRUITING

Related Publications (2)

• Mirabel M, Damy T, Donal E, Huttin O, Labombarda F, Eicher JC, Cervino C, Laurito M, Offredo L, Tafflet M, Jouven X, Giura G, Desnos M, Jeunemaitre X, Empana JP, Charron P, Habib G, Reant P, Hagege A; REMY working group of the French Society of Cardiology. Influence of centre expertise on the diagnosis and management of hypertrophic cardiomyopathy: A study from the French register of hypertrophic cardiomyopathy (REMY). Int J Cardiol. 2019 Jan 15;275:107-113. doi: 10.1016/j.ijcard.2018.09.083. Epub 2018 Sep 28.

  PMID: 30316646 RESULT

• Sakhi H, Soulat G, Craiem D, Gencer U, Lamy J, Stipechi V, Puscas T, Hulot JS, Hagege A, Mousseaux E. Association of Impaired Left Ventricular Mitral Filling from 4D Flow Cardiac MRI and Prognosis of Hypertrophic Cardiomyopathy. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230198. doi: 10.1148/ryct.230198.

  PMID: 38512023 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Systematic search for predisposition genes and Fabry disease in patients with hypertrophic cardiomyopathy (GE-REMY) with blood sampling at baseline or during a consultation normally scheduled as part of the management of this pathology

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Albert Hagege

CONTACT

33(0)156092897; albert.hagege@egp.ap-hop-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 24, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

FR (1)