Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

NCT05772091 | Recruiting

• 1 other identifier: 2022PI171
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Transthyretin Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pr. Nicolas GIRERD: lead

Study Sites (4)

Hôpitaux Universitaires Henri Mondor

Créteil, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

CHU de Rennes Hôpital Pontchaillou

Rennes, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

Study Officials

• Nicolas GIRERD, MD, PhD

  CHRU of Nancy

  STUDY CHAIR

Central Study Contacts

Olivier HUTTIN, MD, PhD

CONTACT

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

Antoine FRAIX, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: September 29, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)