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Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Bidimensional Shear Wave Elastography) in Patients With Transthyretin Amyloidosis

NCT04456582 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-07-02

No results posted yet for this study

Summary

Amyloidosis by mutation of the transthyretin gene (ATTRh) is part of a group of diseases in which the deposit of structurally abnormal proteins (amyloid fibrils) affects multiple organs such as: liver, kidney, eyes, nervous system, gastrointestinal tract and heart, and, finally, it increases the morbidity and mortality of affected patients. This deposit in the myocardium is manifested syndromically as heart failure with preserved or slightly reduced systolic function, and important diastolic dysfunction. The analysis of diastolic function comprises two components: the assessment of active relaxation, dependent on preload and afterload, and the assessment of the passive properties of the tissue - its hardness or rigidity. Myocardial stiffness represents an important parameter for diagnosis and prognosis, but its evaluation is not included in conventional echocardiography. Cardiac elastography has recently been proposed as a non-invasive diagnostic modality to assess myocardial stiffness.

Conditions

  • Amyloidosis

Interventions

PROCEDURE

Shear wave elastography

The elastographic technique by ultrasound (USE), shear waves or shear wave elastography (SWE), quantitatively evaluates tissue stiffness by mapping the propagation of acoustic waves (shear waves), in a non-invasive manner and without emission of ionizing radiation. Their speeds are tracked by the ultrasound equipment after tissue deformation occurs, generated by pulses of acoustic radiation (ARFI) of the transducer itself. Assuming the correlation between tissue stiffness and increased acoustic propagation speeds, it is possible to describe mathematically the elasticity of tissues by measuring specific acoustic waves.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Fábio Fernandes

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2021-01-31
Completion
2021-05-29

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456582 on ClinicalTrials.gov