Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

Valeur Pronostique Dans Une Population d'Amylose Cardiaque Des paramètres échocardiographiques basée Sur Une Approche d'Apprentissage Automatique

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05772091

Acronym

ATTR-AI

Enrollment

1000

Registered

2023-03-16

Start date

2023-09-29

Completion date

2024-03-31

Last updated

2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthyretin Cardiac Amyloidosis

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with suspicion of transthyretin cardiac amyloidosis * Age ≥18 years

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Rate of death from all causes	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	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)

Secondary

Measure	Time frame	Description
Implantation of pacemaker/defibrillator during study	Minimum 1-year follow-up and until last news available	—
Rate of death from all causes	Minimum 1-year follow-up and until last news available	—
Rate of hospitalisation for acute heart failure	Minimum 1-year follow-up and until last news available	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)
Rate of death from all causes and hospitalisation for acute heart failure	Minimum 1-year follow-up and until last news available	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 )
Rate of hospitalisation for acute heart failure (including repeated hospitalisation)	Minimum 1-year follow-up and until last news available	—

Countries

France

Contacts

Primary ContactOlivier HUTTIN, MD, PhD

o.huttin@chru-nancy.fr+ 33 3 83 15 73 55

Backup ContactAntoine FRAIX, MD

a.fraix@chru-nancy.fr+ 33 3 83 15 41 83

Outcome results