Transthyretin Cardiac Amyloidosis Clinical Trial
— ATTR-AIOfficial title:
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pr. Nicolas GIRERD |
France,
| 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 |
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