Clinical trial NCT05772091: Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach
Official title: Valeur Pronostique Dans Une Population d'Amylose Cardiaque Des paramètres échocardiographiques basée Sur Une Approche d'Apprentissage Automatique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transthyretin Cardiac Amyloidosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were managed at participating centers for suspected cardiac amyloidosis or patients with suspected cardiac amyloidosis during hospitalization for another cause.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of death from all causes
timeFrame: Minimum 1-year follow-up and until last news available
measure: Rate of hospitalisation for acute heart failure
timeFrame: Minimum 1-year follow-up and until last news available
Secondary outcomes:
measure: Rate of death from all causes
timeFrame: Minimum 1-year follow-up and until last news available
measure: Rate of hospitalisation for acute heart failure (including repeated hospitalisation)
timeFrame: Minimum 1-year follow-up and until last news available
measure: Implantation of pacemaker/defibrillator during study
timeFrame: Minimum 1-year follow-up and until last news available
measure: Rate of death from all causes and hospitalisation for acute heart failure
timeFrame: Minimum 1-year follow-up and until last news available
measure: Rate of death from all causes
timeFrame: Minimum 1-year follow-up and until last news available
measure: Rate of hospitalisation for acute heart failure
timeFrame: Minimum 1-year follow-up and until last news available
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpitaux Universitaires Henri Mondor
city: Nancy
country: France
facility: CHRU de Nancy
city: Rennes
country: France
facility: CHU de Rennes Hôpital Pontchaillou
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHRU of Nancy
name: Nicolas GIRERD, MD, PhD
role: STUDY_CHAIR
References: