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

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.

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Key information

Conditions

Transthyretin Cardiac Amyloidosis

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

C.H.U. de Poitiers

Poitiers, 86000, France

About this study

Not Provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bony scintigraphy

Procedure

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

Primary outcomes

Percentage of patients with a positive bone scintigraphy (perugini score> or = 2) in the absence of AL cardiac amyloidosis.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

Pfizer

Registry information

Acronym: IMPACT

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Oct 1, 2021
Registry last updated: Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed