Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

Recruiting

• Conditions: Transthyretin Cardiac Amyloidosis

• Registration Number: NCT05772091
• Lead Sponsor: Pr. Nicolas GIRERD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-16
• Study Start: 2023-09-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
Implantation of pacemaker/defibrillator during study	Minimum 1-year follow-up and until last news available
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	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	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 8)
Rate of hospitalisation for acute heart failure (including repeated hospitalisation)	Minimum 1-year follow-up and until last news available

Trial Locations

Locations (4)

CHU de Toulouse; 🇫🇷 Toulouse, France

Hôpitaux Universitaires Henri Mondor; 🇫🇷 Créteil, France

CHU de Rennes Hôpital Pontchaillou; 🇫🇷 Rennes, France

CHRU de Nancy; 🇫🇷 Nancy, France