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

NCT05064839 | Completed Phase 3

• 1 other identifier: 2021-A00732-39
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 1

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.

Conditions

Transthyretin Cardiac Amyloidosis

Keywords

cardiology

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Bony scintigraphy

EXPERIMENTAL

Bony scintigraphy within 1 to 4 months after inclusion

Procedure: Bony scintigraphy

Interventions

Bony scintigraphy PROCEDURE

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

Bony scintigraphy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Pfizer: collaborator

Study Sites (1)

C.H.U. de Poitiers

Poitiers, 86000, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: October 1, 2021
• Study Start: October 6, 2021
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

FR (1)