Hypertrophic Cardiomyopathy2022PI172NCT06256913
Machine Learning Approach Based on Echocardiographic Data to Improve Prediction of Cardiovascular Events in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Pr. Nicolas GIRERD at 2 sites in France.
Trial summary
Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 870 participants
- Where
- 2 sitesFrance
- Study dates
- 6 May 2023to 6 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed sarcomeric hypertrophic cardiomyopathy population
Who may be able to join
- Age >18
- Patients with confirmed sarcomeric hypertrophic cardiomyopathy
Who cannot join
- Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
- Other causes of left ventricular hypertrophy that may hamper the diagnosis (p.e. aortic or sub-aortic stenosis, severe renal insufficiency, hypertension).
- History of ischemic heart disease or associated myocarditis
- Opposition of the patient to the use of his/her data
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Boredeaux Hôpital Cardiologique du Haut-Lévêque
Bordeaux
Patricia Reant, MD
- Recruiting
CHRU de Nancy
Nancy
HUTTIN Olivier, MD, PhD, o.huttin@chru-nancy.fr
About this study
Official title: Phénogroupage basé Sur l'Apprentissage Automatique Dans la Cardiomyopathie Hypertrophique Pour Identifier Les Facteurs prédictifs de la Fibrose Myocardique et Les événements Cardiovasculaires
Hypertrophic cardiomyopathy is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure.
The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.
- Conditions
- Hypertrophic Cardiomyopathy
- 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 sarcomeric hypertrophic cardiomyopathy and cardiovascular events | Patients with confirmed sarcomeric hypertrophic cardiomyopathy who experienced cardiovascular events. | |
| Patients with sarcomeric hypertrophic cardiomyopathy free of cardiovascular events | Patients with confirmed sarcomeric hypertrophic cardiomyopathy free of cardiovascular events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality (composite)
Rates of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 2,3,4,5,6)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Hospitalisation for cardiovascular event (composite)
Rates of cardiovascular mortality, hospitalization for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,3,4,5,6)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Worsening of NYHA stage (composite)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,4,5,6)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Onset of ventricular arrhythmia (composite)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3, 5,6)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Onset of supra ventricular arrhythmia (composite)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3,4,6)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,3,4,5)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Secondary outcomes (7)
Onset of tachycardia and or atrial fibrillation
Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 8)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Sudden death, recovered or not recovered
Tachycardia and/or ventricular fibrillation during follow-up as well as sudden death, recovered or not recovered. (With outcome 7)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac decompensation requiring IV diuretics intake
Composite endpoint: cardiac decompensation requiring IV diuretics intake (managed in conventional hospitalization, day hospitalization or in-home) and the occurrence of atrial fibrillation, atrial tachycardia or atrial flutter. (With outcome 10)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter
Composite endpoint: cardiac decompensation requiring IV diuretics intake (managed in conventional hospitalization, day hospitalization or in-home) and the occurrence of atrial fibrillation, atrial tachycardia or atrial flutter. (With outcome 9)
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Evaluated by measurement of left ventricular mass as well as the appearance of late enhancement on MRI.
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Evaluated by measurement of volume as well as the appearance of late enhancement on MRI.
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Evaluated by measurement of function as well as the appearance of late enhancement on MRI.
Measured: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start6 May 2023
- Primary completion6 May 2024 (estimated)
- Study completion6 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas Girerd, MD, Study chair, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256913
- Sponsor's protocol ID
- 2022PI172
- Acronym
- 2022PI172
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phénogroupage basé Sur l'Apprentissage Automatique Dans la Cardiomyopathie Hypertrophique Pour Identifier Les Facteurs prédictifs de la Fibrose Myocardique et Les événements Cardiovasculaires
- ClinicalTrials.gov ID
- NCT06256913
- Acronym / sponsor ID
- 2022PI172 / 2022PI172
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 6 May 2024 (estimated)
- Study completion
- 6 May 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- 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 is a pathology with a highly variable course, ranging from patients who are asymptomatic throughout their lives to those who experience sudden death and/or terminal heart failure.
The main objective is to develop and validate an algorithm (constructed through supervised learning) using cardiac imaging data to predict the risk of cardiovascular events in sarcomeric hypertrophic cardiomyopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sarcomeric hypertrophic cardiomyopathy and cardiovascular events | – | –Patients with confirmed sarcomeric hypertrophic cardiomyopathy who experienced cardiovascular events. |
| Patients with sarcomeric hypertrophic cardiomyopathy free of cardiovascular events | – | –Patients with confirmed sarcomeric hypertrophic cardiomyopathy free of cardiovascular events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed sarcomeric hypertrophic cardiomyopathy population
Key inclusion criteria (2 listed)
- Age >18
- Patients with confirmed sarcomeric hypertrophic cardiomyopathy
Key exclusion criteria (4 listed)
- Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
- Other causes of left ventricular hypertrophy that may hamper the diagnosis (p.e. aortic or sub-aortic stenosis, severe renal insufficiency, hypertension).
- History of ischemic heart disease or associated myocarditis
- Opposition of the patient to the use of his/her data
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
Cardiovascular mortality (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Rates of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 2,3,4,5,6)
Hospitalisation for cardiovascular event (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Rates of cardiovascular mortality, hospitalization for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,3,4,5,6)
Worsening of NYHA stage (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,4,5,6)
Onset of ventricular arrhythmia (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3, 5,6)
Onset of supra ventricular arrhythmia (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1, 2,3,4,6)
Onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (composite)
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Proportion of cardiovascular mortality, hospitalisation for cardiovascular event, worsening of NYHA stage, onset of ventricular arrhythmia, onset of supra ventricular arrhythmia, onset of peripheral embolisms (stroke, TIA or acute limb ischemia) (With outcome 1,2,3,4,5)
7 secondary outcomes
Onset of tachycardia and or atrial fibrillation
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Sudden death, recovered or not recovered
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac decompensation requiring IV diuretics intake
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Occurrence of atrial fibrillation, atrial tachycardia or atrial flutter
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Cardiac remodelling
Time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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. This study is not recruiting at the moment.
Nicolas Girerd, MD study chair
CHRU de Nancy
2 sites 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 Pr. Nicolas GIRERD at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Huttin, MD, PhD (+ 33 3 83 15 73 55, o.huttin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality (composite) (time frame: From date of start of follow-up until death or loss to follow-up (up to 12 years of FU)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.