Skip to main content
Clinical Trials/NCT05772091
NCT05772091
Recruiting
Not Applicable

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

Pr. Nicolas GIRERD4 sites in 1 country1,000 target enrollmentSeptember 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transthyretin Cardiac Amyloidosis
Sponsor
Pr. Nicolas GIRERD
Enrollment
1000
Locations
4
Primary Endpoint
Rate of hospitalisation for acute heart failure
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2023
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pr. Nicolas GIRERD
Responsible Party
Sponsor Investigator
Principal Investigator

Pr. Nicolas GIRERD

Professor

Central Hospital, Nancy, France

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

Outcomes

Primary Outcomes

Rate of hospitalisation for acute heart failure

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 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)
  • Rate of hospitalisation for acute heart failure (including repeated hospitalisation)(Minimum 1-year follow-up and until last news available)

Study Sites (4)

Loading locations...

Similar Trials