Transthyretin Cardiac AmyloidosisATTR-AINCT05772091
Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach
An observational study of Transthyretin Cardiac Amyloidosis, run by Pr. Nicolas GIRERD at 4 sites in France.
Trial summary
Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Cardiac Amyloidosis
- How many people
- 1,000 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Sep 2023to 31 Mar 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: Patients who were managed at participating centers for suspected cardiac amyloidosis or patients with suspected cardiac amyloidosis during hospitalization for another cause.
Who may be able to join
- Patients with suspicion of transthyretin cardiac amyloidosis
- Age ≥18 years
Who cannot join
- Lack of data to confirm or overturn the transthyretin amyloidosis diagnostic
- Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
- Final diagnostic of AL or AA amyloidosis
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Not yet recruiting
Hôpitaux Universitaires Henri Mondor
Créteil
Thibaud DAMY, MD
- Recruiting
CHRU de Nancy
Nancy
Antoine FRAIX, MD
- Not yet recruiting
CHU de Rennes Hôpital Pontchaillou
Rennes
Erwan DONNAL, MD
- Not yet recruiting
CHU de Toulouse
Toulouse
Olivier LAIREZ, MD
About this study
Official title: Valeur Pronostique Dans Une Population d'Amylose Cardiaque Des paramètres échocardiographiques basée Sur Une Approche d'Apprentissage Automatique
Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Still currently incurable, the evolution of this pathology is burdened by numerous comorbidities, including iterative hospitalizations for heart failure leading to death. The Machine Learning approach has already shown its efficiency in terms of diagnosis but its prognostic approach has not yet been studied.
- Conditions
- Transthyretin Cardiac Amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of death from all causes
composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 2
Measured: Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure
composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 1)
Measured: Minimum 1-year follow-up and until last news available
Secondary outcomes (6)
Rate of death from all causes
Measured: Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure (including repeated hospitalisation)
Measured: Minimum 1-year follow-up and until last news available
Implantation of pacemaker/defibrillator during study
Measured: Minimum 1-year follow-up and until last news available
Rate of death from all causes and hospitalisation for acute heart failure
composite endpoint: Rate of death from all causes and hospitalisation for acute heart failure, rate of death from all causes and rate of hospitalisation for acute heart failure following inclusion (with outcome 7 and )
Measured: Minimum 1-year follow-up and until last news available
Rate of death from all causes
composite endpoint: Rate of death from all causes and hospitalisation for acute heart failure, rate of death from all causes and rate of hospitalisation for acute heart failure following inclusion (with outcome 6 and 8)
Measured: Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of death from all causes and hospitalisation for acute heart failure, rate of death from all causes and rate of hospitalisation for acute heart failure following inclusion (with outcome 6 and 7)
Measured: Minimum 1-year follow-up and until last news available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start29 Sep 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Cardiac AmyloidosisStudies 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
- 1,000 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, PhD, Study chair, CHRU of Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772091
- Sponsor's protocol ID
- 2022PI171
- Acronym
- ATTR-AI
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valeur Pronostique Dans Une Population d'Amylose Cardiaque Des paramètres échocardiographiques basée Sur Une Approche d'Apprentissage Automatique
- ClinicalTrials.gov ID
- NCT05772091
- Acronym / sponsor ID
- ATTR-AI / 2022PI171
- Conditions
- Transthyretin Cardiac Amyloidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 16 Mar 2023 (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.
Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Still currently incurable, the evolution of this pathology is burdened by numerous comorbidities, including iterative hospitalizations for heart failure leading to death. The Machine Learning approach has already shown its efficiency in terms of diagnosis but its prognostic approach has not yet been studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were managed at participating centers for suspected cardiac amyloidosis or patients with suspected cardiac amyloidosis during hospitalization for another cause.
Key inclusion criteria (2 listed)
- Patients with suspicion of transthyretin cardiac amyloidosis
- Age ≥18 years
Key exclusion criteria (3 listed)
- Lack of data to confirm or overturn the transthyretin amyloidosis diagnostic
- Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
- Final diagnostic of AL or AA amyloidosis
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
Rate of death from all causes
Time frame: Minimum 1-year follow-up and until last news available
composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 2
Rate of hospitalisation for acute heart failure
Time frame: Minimum 1-year follow-up and until last news available
composite endpoint: rate of death from all causes and hospitalisation for acute heart failure following inclusion (with outcome 1)
6 secondary outcomes
Rate of death from all causes
Time frame: Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure (including repeated hospitalisation)
Time frame: Minimum 1-year follow-up and until last news available
Implantation of pacemaker/defibrillator during study
Time frame: Minimum 1-year follow-up and until last news available
Rate of death from all causes and hospitalisation for acute heart failure
Time frame: Minimum 1-year follow-up and until last news available
Rate of death from all causes
Time frame: Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure
Time frame: Minimum 1-year follow-up and until last news available
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Transthyretin Cardiac Amyloidosis
Active, not recruitingPhase 3
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
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, PhD study chair
CHRU of Nancy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Cardiac Amyloidosis, run by Pr. Nicolas GIRERD at 4 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 3 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Rate of death from all causes (time frame: Minimum 1-year follow-up and until last news available). The study lists 2 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 28 Mar 2024.