Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

Transthyretin Cardiac Amyloidosis Clinical Trial

— ATTR-AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772091
• Other study ID #: 2022PI171
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Central Hospital, Nancy, France
• Contact: Olivier HUTTIN, MD, PhD
• Phone: + 33 3 83 15 73 55
• Email: o.huttin[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Transthyretin Cardiac Amyloidosis

Locations

Country	Name	City	State
France	Hôpitaux Universitaires Henri Mondor	Créteil
France	CHRU de Nancy	Nancy
France	CHU de Rennes Hôpital Pontchaillou	Rennes
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Pr. Nicolas GIRERD

Country where clinical trial is conducted

France, 

Outcome

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