Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

Phase 3

Completed

• Conditions: Transthyretin Cardiac Amyloidosis
• Interventions: Procedure: Bony scintigraphy

• Registration Number: NCT05064839
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

Detailed Description

Not Provided

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-01
• Study Start: 2021-10-06
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

Inclusion Criteria

• Patient ≥ 60 years, hospitalised in cardiology wards of the Centre Hospitalier Universitaire of Poitiers
• Left ventricle hypertrophy on echocardiography
• Patient able to comply with study procedures
• Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
• Patient having signed an informed consent after clear and fair information on the study

Exclusion Criteria

• CardiacTransplant
• Complex congenital cardiopathies
• Know diagnosis of amylosis
• Contra-indication to bony scintigraphy : hypersensitivity to sodium oxidronate or one of its excipients, or to one of the components of radiopharmaceutic marked product ;
• Subject not able to comply with study procedures
• Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
• Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection, and patients in emergency situation.
• Women not menopausal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bony scintigraphy	Bony scintigraphy	Bony scintigraphy within 1 to 4 months after inclusion

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.	At Visit 2, one to four months after inclusion visit.	Percentage of patients with a positive bone scintigraphy (perugini score\> or = 2) in the absence of AL cardiac amyloidosis in patients over 60 years hospitalised in cardiology wards, with an hypertrophy of the left ventricle on transthoracic echocardiography (thickness of the left ventricle at the end of diastole \>12mm), whatever the possible cause of hypertrophy of the left ventricle (other potential cause not excluded), and without prior diagnosis of cardiac amylosis.

Trial Locations

Locations (1)

C.H.U. de Poitiers; 🇫🇷 Poitiers, France