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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064839
Other study ID # 2021-A00732-39
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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