Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04893889
Status:
UNKNOWN
Last Update Posted:
2021-05-20
First Post:
2021-05-14
Brief Title:
Substudy NCT04456582 Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique Two-dimensional Shear Wave Elastography in Patients With Amyloidosis and Fabry Disease
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Substudy NCT04456582 Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique Two-dimensional Shear Wave Elastography in Patients With Amyloidosis and Fabry Disease
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FABRY
Brief Summary:
Introduction Heart failure with preserved systolic function encompasses several different diseases but which have diastolic dysfunction and its components in common myocardial stiffness and altered relaxation Myocardial stiffness represents an important parameter for diagnosis and prognosis but only changes in relaxation are evaluated in clinical practice Cardiac elastography has been proposed as a diagnostic modality for noninvasive assessment of myocardial stiffness
Objective The aim of our study is to investigate the potential of myocardial elastography by shear waves to assess myocardial stiffness by non-invasively quantifying diastolic myocardial elasticity EMD in Fabry disease DF and cardiac amyloidosis AC in the ATTRh form and correlate with other complementary imaging and laboratory tests electrocardiogram 2D echocardiogram troponin and BNP and with a 6-minute walk test and quality of life questionnaires
Material and methods 60 adults will be prospectively included 20 patients with Fabry disease 40 patients with hRTRT 20 with cardiac involvement and 20 patients as a control group Echocardiography electrocardiogram and laboratory evaluations will be performed The elastocardiographic assessment of myocardial stiffness will be performed in ultrasound equipment Canon Aplio i800 using a multifrequency convex transducer under specific adjustment of the equipment to perform myocardial elastography
Objective The aim of our study is to investigate the potential of myocardial elastography by shear waves to assess myocardial stiffness by non-invasively quantifying diastolic myocardial elasticity EMD in Fabry disease DF and cardiac amyloidosis AC in the ATTRh form and correlate with other complementary imaging and laboratory tests electrocardiogram 2D echocardiogram troponin and BNP and with a 6-minute walk test and quality of life questionnaires
Material and methods 60 adults will be prospectively included 20 patients with Fabry disease 40 patients with hRTRT 20 with cardiac involvement and 20 patients as a control group Echocardiography electrocardiogram and laboratory evaluations will be performed The elastocardiographic assessment of myocardial stiffness will be performed in ultrasound equipment Canon Aplio i800 using a multifrequency convex transducer under specific adjustment of the equipment to perform myocardial elastography
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None