Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach (ATTR-AI)

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.

Study Overview

• Status: Recruiting
• Conditions: Transthyretin Cardiac Amyloidosis

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Olivier HUTTIN, MD, PhD; Phone Number: + 33 3 83 15 73 55; Email: o.huttin@chru-nancy.fr
• Study Contact Backup: Name: Antoine FRAIX, MD; Phone Number: + 33 3 83 15 41 83; Email: a.fraix@chru-nancy.fr

Study Locations

• France
  • Créteil, France
    • Not yet recruiting
    • Hôpitaux Universitaires Henri Mondor
    • Contact: Thibaud DAMY, MD
  • Nancy, France
    • Recruiting
    • CHRU de Nancy
    • Contact: Antoine FRAIX, MD
  • Rennes, France
    • Not yet recruiting
    • CHU de Rennes Hôpital Pontchaillou
    • Contact: Erwan DONNAL, MD
  • Toulouse, France
    • Not yet recruiting
    • CHU de Toulouse
    • Contact: Olivier LAIREZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of death from all causes		Minimum 1-year follow-up and until last news available
Rate of hospitalisation for acute heart failure (including repeated hospitalisation)		Minimum 1-year follow-up and until last news available
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	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
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
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

Collaborators and Investigators

• Sponsor: Pr. Nicolas GIRERD
• Investigators: Study Chair: Nicolas GIRERD, MD, PhD, CHRU of Nancy

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 2022PI171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No