Hereditary Heart DiseasesPREVENTNCT07257289
Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
An observational study of Hereditary Heart Diseases, run by Nantes University Hospital at 15 sites in 3 countries.
Trial summary
Sudden cardiac death (SCD) is one of the leading causes of death in developed countries. These deaths (more than 5,000 per year in France) are due to hereditary arrhythmias or cardiomyopathies. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Hereditary Heart Diseases
- What is being tested?
- Blood sample
- How many people
- 1,000 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 3 Feb 2026to 12 Dec 2036
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult and minor patients with hereditary heart disease or cardiomyopathies and their relatives.
Who may be able to join
- hereditary heart disease II. All relatives of patients III. Patients referred to the reference centre for suspected hereditary rhythm disorders or cardiomyopathies IV. Written consent V. social security scheme
Who cannot join
- Patients participating in a therapeutic trial that may interfere with the research results II. Patients under guardianship or curatorship.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Aurélie Thollet contact
15 sites in 3 countries
France13 sites, 13 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux
SACHER Frédéric, frederic.sacher@chubordeaux.fr
- Not yet recruiting
CHU de Brest
Brest
MANSOURATI Jacques, jacques.mansourati@chu-brest.fr
- Not yet recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
ESCHALIER Romain, reschalier@chu-clermontferrand.fr
- Not yet recruiting
CHU de Dijon
Dijon
LAURENT Gabriel, gabriel.laurent@chu-dijon.fr
- Not yet recruiting
CHU de La Rochelle
La Rochelle
AL-ARNAOUT Alain, alain.alarnaout@ght-atlantique17.fr
- Not yet recruiting
CHU de Limoges
Limoges
GUY-MOYAT Benoît, benoit.guy-moyat@chu-limoges.fr
- Not yet recruiting
CHU de Montpellier
Montpellier
PASQUIE Jean-Luc, jl-pasquie@chu-montpellier.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Probst Vincent, PUPH, +33 240165699, vincent.probst@chu-nantes.fr
- Not yet recruiting
CHU de Poitiers
Poitiers
GARCIA Rodrigue, rodrigue.garcia@chu-poitiers.fr
- Not yet recruiting
CHU de Rennes
Rennes
BEHAR Nathalie, nathalie.behar@chu-rennes.fr
- Not yet recruiting
CHU de Strasbourg
Strasbourg
JESEL Laurence, laurence.jesel@chru-strasbourg.fr
- Not yet recruiting
CHU de Toulouse
Toulouse
MAURY Philippe, maury.p@chu-toulouse.fr
- Not yet recruiting
CHU de Tours
Tours
PIERRE Bertrand, b.pierre@chu-tours.fr
Martinique1 site, 1 recruiting
- Not yet recruiting
CHU de la Martinique
Fort-de-France
DEMONIERE Fabrice, fabrice.demoniere@chu-martinique.fr
Reunion1 site, 1 recruiting
- Not yet recruiting
CHU de la Réunion
Saint-Pierre
WIART François, francois.wiart@chu-reunion.fr
About this study
Sudden cardiac death (SCD) is one of the leading causes of death in developed countries. These deaths (more than 5,000 per year in France) are due to hereditary arrhythmias or cardiomyopathies. Early diagnosis of SCD is often achieved through family screening, but the main challenge is to stratify the risk of SCD in these patients. Indeed, prevention of SCD relies mainly on the implantation of an automatic defibrillator. The challenge is to identify patients who will develop SCD and avoid implanting an implantable cardioverter defibrillator (ICD) in patients who will never develop arrhythmias but who will face complications related to the ICD (inappropriate shocks, infection, lead failure), leading to a reduced quality of life and significant costs for the healthcare system. However, there is a lack of relevant clinical and biological markers for risk stratification, which rules out any possibility of preventive screening. Most of the clinical and ECG (electrocardiogram) parameters identifying an increased risk of SCD have not been reproduced in replication studies.
In this project, the investigator will develop a data processing and analysis pipeline using artificial intelligence methods to assess the individual risk of serious arrhythmic events or heart failure in patients with hereditary arrhythmic diseases or cardiomyopathies through the automated processing of multimodal data (clinical data, electrocardiogram (ECG), imaging (echocardiography, MRI magnetic resonance imaging), genetic data, biomarkers).
Read the detailed description
The eligibility of patients (index cases and related cases) for the study will be determined during a cardiology consultation or day hospitalisation, carried out as part of routine care.
The investigator undertakes to obtain the person's free, informed and express consent, collected in writing, after providing them with oral and written information on the protocol and allowing them sufficient time to reflect. In the case of a minor patient, the investigator undertakes to inform the minor patient and their legal representatives orally and in writing and to obtain the minor's assent, i.e. their oral or written agreement depending on their age, and the written consent of their legal representatives.
Specific acts for research:
- Collection of two additional EDTA tubes (2 x 5 ml) during a blood test carried out as part of routine care, except for minors under the age of 4, for whom a saliva sample will be offered instead.
- Collection of one dry tube (5 ml) during a blood test carried out as part of routine care for biomarker analysis and only for adult patients from Nantes University Hospital.
Clinical data will be collected in a parameterised and secure eCRF (electronic Case Report Form).
Patients will be followed in the routine care for maximum 10 years. Arrhythmias, heart failure and sudden cardiac death will be collected during follow-up.
A data processing and analysis pipeline using artificial intelligence methods to assess the individual risk of serious arrhythmic events or heart failure in patients with hereditary arrhythmic diseases or cardiomyopathies through the automated processing of multimodal data (clinical data, electrocardiogram (ECG), imaging (echocardiography, MRI magnetic resonance imaging), genetic data, biomarkers) will be developped.
- Conditions
- Hereditary Heart Diseases
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Collection of two additional EDTA tubes (2 x 5 ml) blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmic and heart failure risk stratification
to assess the arrhythmic risk and/or risk of heart failure in patients with hereditary heart disease at 5, 8 and 10 years, using a model combining clinical, electrocardiographic, imaging, genetic and biomarker data.
Measured: 5, 8 and 10 years
Secondary outcomes (2)
Demographics data
Determine the risk of arrhythmia and/or heart failure based on demographics data
Measured: 5, 8 and 10 years
Diagnosis of Brugada syndrome
Evaluate the diagnostic performance of the model combining clinical, electrocardiographic, genetic and biomarker data for the identification of Brugada syndrome.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start3 Feb 2026
- Primary completion3 Feb 2036 (estimated)
- Study completion12 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257289
- Sponsor's protocol ID
- RC25_0107
- Acronym
- PREVENT
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2025
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Arrhythmic Risk and/or Heart Failure Risk in Patients With Hereditary Heart Disease
- ClinicalTrials.gov ID
- NCT07257289
- Acronym / sponsor ID
- PREVENT / RC25_0107
- Conditions
- Hereditary Heart Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 3 Feb 2036 (estimated)
- Study completion
- 12 Dec 2036 (estimated)
- First posted
- 2 Dec 2025 (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.
Sudden cardiac death (SCD) is one of the leading causes of death in developed countries. These deaths (more than 5,000 per year in France) are due to hereditary arrhythmias or cardiomyopathies. Early diagnosis of SCD is often achieved through family screening, but the main challenge is to stratify the risk of SCD in these patients. Indeed, prevention of SCD relies mainly on the implantation of an automatic defibrillator. The challenge is to identify patients who will develop SCD and avoid implanting an implantable cardioverter defibrillator (ICD) in patients who will never develop arrhythmias but who will face complications related to the ICD (inappropriate shocks, infection, lead failure), leading to a reduced quality of life and significant costs for the healthcare system. However, there is a lack of relevant clinical and biological markers for risk stratification, which rules out any possibility of preventive screening. Most of the clinical and ECG (electrocardiogram) parameters identifying an increased risk of SCD have not been reproduced in replication studies.
In this project, the investigator will develop a data processing and analysis pipeline using artificial intelligence methods to assess the individual risk of serious arrhythmic events or heart failure in patients with hereditary arrhythmic diseases or cardiomyopathies through the automated processing of multimodal data (clinical data, electrocardiogram (ECG), imaging (echocardiography, MRI magnetic resonance imaging), genetic data, biomarkers).
Detailed description
The eligibility of patients (index cases and related cases) for the study will be determined during a cardiology consultation or day hospitalisation, carried out as part of routine care.
The investigator undertakes to obtain the person's free, informed and express consent, collected in writing, after providing them with oral and written information on the protocol and allowing them sufficient time to reflect. In the case of a minor patient, the investigator undertakes to inform the minor patient and their legal representatives orally and in writing and to obtain the minor's assent, i.e. their oral or written agreement depending on their age, and the written consent of their legal representatives.
Specific acts for research:
- Collection of two additional EDTA tubes (2 x 5 ml) during a blood test carried out as part of routine care, except for minors under the age of 4, for whom a saliva sample will be offered instead.
- Collection of one dry tube (5 ml) during a blood test carried out as part of routine care for biomarker analysis and only for adult patients from Nantes University Hospital.
Clinical data will be collected in a parameterised and secure eCRF (electronic Case Report Form).
Patients will be followed in the routine care for maximum 10 years. Arrhythmias, heart failure and sudden cardiac death will be collected during follow-up.
A data processing and analysis pipeline using artificial intelligence methods to assess the individual risk of serious arrhythmic events or heart failure in patients with hereditary arrhythmic diseases or cardiomyopathies through the automated processing of multimodal data (clinical data, electrocardiogram (ECG), imaging (echocardiography, MRI magnetic resonance imaging), genetic data, biomarkers) will be developped.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult and minor patients with hereditary heart disease or cardiomyopathies and their relatives.
Key inclusion criteria (1 listed)
- hereditary heart disease II. All relatives of patients III. Patients referred to the reference centre for suspected hereditary rhythm disorders or cardiomyopathies IV. Written consent V. social security scheme
Key exclusion criteria (1 listed)
- Patients participating in a therapeutic trial that may interfere with the research results II. Patients under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleCollection of two additional EDTA tubes (2 x 5 ml) blood sample | Biological | – |
Primary outcome
Arrhythmic and heart failure risk stratification
Time frame: 5, 8 and 10 years
to assess the arrhythmic risk and/or risk of heart failure in patients with hereditary heart disease at 5, 8 and 10 years, using a model combining clinical, electrocardiographic, imaging, genetic and biomarker data.
2 secondary outcomes
Demographics data
Time frame: 5, 8 and 10 years
Diagnosis of Brugada syndrome
Time frame: 5 years
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 27 Oct 2026.
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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.
Aurélie Thollet contact
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Heart Diseases, run by Nantes University Hospital at 15 sites in 3 countries.
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 1 inclusion and 1 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Martinique, Reunion. 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 Vincent Probst, PU-PH (02 40 16 56 99, vincent.probst@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmic and heart failure risk stratification (time frame: 5, 8 and 10 years). 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 27 Oct 2026.