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

Transthyretin Cardiac Amyloidosis Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064839
• Other study ID #: 2021-A00732-39
• Status: Completed
• Phase: Phase 3
• Start date: October 6, 2021
• Est. completion date: August 18, 2023

Study information

• Verified date: September 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not Provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Transthyretin Cardiac Amyloidosis

Intervention

Procedure:
• Bony scintigraphy
Bony scintigraphy (99mTc-Hydromethylene diphosphonate) will be performed in all patients with hypertrophy of the left ventricle

Locations

Country	Name	City	State
France	C.H.U. de Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.	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.	At Visit 2, one to four months after inclusion visit.