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

NCT ID: NCT05064839

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2023-08-18

Brief Summary

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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

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Not Provided

Conditions

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Transthyretin Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Bony scintigraphy

Bony scintigraphy within 1 to 4 months after inclusion

Group Type EXPERIMENTAL

Bony scintigraphy

Intervention Type PROCEDURE

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

Interventions

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Bony scintigraphy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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C.H.U. de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00732-39

Identifier Type: -

Identifier Source: org_study_id

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