Hypertrophic CardiomyopathyREMYNCT01091480
French Hypertrophic Cardiomyopathy Observatory
An observational study of Hypertrophic Cardiomyopathy, run by French Cardiology Society at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Expressed refusal to participate in the study
- Significant aortic stenosis (<1 cm ²)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
European Georges Pompidou Hospital
Paris, 75015
Albert Hagege, 33(0)156093683, albert.hagege@egp.ap-hop-paris.fr
Albert Hagege
About this study
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)
Read the 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
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic cardiomyopathy, Observatory, LVH
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: 3 years
Secondary outcomes (1)
Diagnostic methods
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).
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2023 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagege Albert, French Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091480
- Sponsor's protocol ID
- 09273
- Acronym
- REMY
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2010
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30316646Sakhi 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.
PubMed 38512023
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Hypertrophic Cardiomyopathy Observatory
- ClinicalTrials.gov ID
- NCT01091480
- Acronym / sponsor ID
- REMY / 09273
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic cardiomyopathy, Observatory, LVH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Mar 2010 (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.
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)
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Expressed refusal to participate in the study
- Significant aortic stenosis (<1 cm ²)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event-free survival
Time frame: 3 years
1 secondary outcome
Diagnostic methods
Time frame: 0 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Results publication: PubMed 30316646Mirabel 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.
- Derived from this study: PubMed 38512023Sakhi 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by French Cardiology Society at 1 site in France.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Hagege (33(0)156092897, albert.hagege@egp.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: 3 years). 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 NCT01091480, which also lists 2 linked publications.
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 21 Sep 2022.