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

NCT04456582

Last updated date
Study Location
University of Sao Paulo Medical School - The Heart Institute
Sao Paulo, , 05403-000, Brazil
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Amyloidosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Documented diagnosis of HRTR with and without cardiac involvement.

- For the definition of cardiac involvement by ATTRh, all the criteria below must be presented:

- Pathogenic mutation of TTR consistent with ATTRh.

- Evidence of cardiac commitment by echocardiography or nuclear magnetic resonance with measurement of the interventricular septum at the end of diastole (SIVd)> 12mm or / and medical history of heart failure, and / or levels of troponin and / or BNP above the reference value without another more likely cause.

- Amyloid deposit in cardiac or extra-cardiac tissue (eg, abdominal fat aspirate, salivary gland, connective sheath of the median nerve) confirmed by congo red staining or presence of grade 2 or 3 myocardial scintigraphy (DPD-CT) of cardiac uptake, in cases where the presence of monoclonal gammopathy of undetermined significance (MGUS) was ruled out.

- In the presence of MGUS, confirmation of the TTR protein in the tissue is necessary through immunohistochemistry (IHC) or mass spectrometry.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Presence of another type of cardiomyopathy such as hypertension, valve or ischemic
heart disease (eg, previous myocardial infarction documented with myocardial necrosis
markers and electrocardiographic changes).


- Presence of diseases other than cardiac amyloidosis, impairing the assessment of
functional capacity, such as chronic obstructive pulmonary disease, severe arthritis
or peripheral arterial disease, recent or planned orthopedic procedure during the
course of the study (eg, spine surgery or under lower limbs) that impairs walking in
the 6-minute test evaluation.


- Acute coronary heart disease or unstable angina in the past 3 months


- Report of disease of the sinus or atrioventricular node with indication of a
pacemaker, but with no intention of implantation.


- Presence of untreated hypothyroidism or hyperthyroidism.


- Previous heart, liver or other organ transplant.


- Presence of neoplasia in the last 3 years, except for basal and squamous cell
carcinomas of skin or cervical cancer in situ previously treated.


- Presence of other medical conditions or comorbidities that, in the investigator's
opinion, could interfere with the course of the study or the interpretation of the
data.


- Pregnancy.


- History of alcohol abuse in the last 2 years or excessive daily alcohol intake (for
women, more than 14 units per week; for men, more than 21 units of alcohol per week
[unit: one glass of wine (125ml) = one dose of distillate = 332.5ml of beer).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Bidimensional Shear Wave Elastography) in Patients With Transthyretin Amyloidosis
Official Title  ICMJE Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Bidimensional Shear Wave Elastography) in Patients With Transthyretin Amyloidosis
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyloidosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Amyloidosis transthyretin with cardiac commitment
    Shear wave elastography (SWE) will be used to evaluate to assess miocardial elasticity.
    Intervention: Procedure: Shear wave elastography
  • Experimental: Amyloidosis transthyretin without cardiac commitment
    Shear wave elastography (SWE) will be used to evaluate to assess miocardial elasticity.
    Intervention: Procedure: Shear wave elastography
  • Placebo Comparator: Healthy subjects
    Shear wave elastography (SWE) will be used to evaluate to assess miocardial elasticity.
    Intervention: Procedure: Shear wave elastography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 29, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of HRTR with and without cardiac involvement.
  • For the definition of cardiac involvement by ATTRh, all the criteria below must be presented:

    • Pathogenic mutation of TTR consistent with ATTRh.
    • Evidence of cardiac commitment by echocardiography or nuclear magnetic resonance with measurement of the interventricular septum at the end of diastole (SIVd)> 12mm or / and medical history of heart failure, and / or levels of troponin and / or BNP above the reference value without another more likely cause.
    • Amyloid deposit in cardiac or extra-cardiac tissue (eg, abdominal fat aspirate, salivary gland, connective sheath of the median nerve) confirmed by congo red staining or presence of grade 2 or 3 myocardial scintigraphy (DPD-CT) of cardiac uptake, in cases where the presence of monoclonal gammopathy of undetermined significance (MGUS) was ruled out.
    • In the presence of MGUS, confirmation of the TTR protein in the tissue is necessary through immunohistochemistry (IHC) or mass spectrometry.

Exclusion Criteria:

  • Presence of another type of cardiomyopathy such as hypertension, valve or ischemic heart disease (eg, previous myocardial infarction documented with myocardial necrosis markers and electrocardiographic changes).
  • Presence of diseases other than cardiac amyloidosis, impairing the assessment of functional capacity, such as chronic obstructive pulmonary disease, severe arthritis or peripheral arterial disease, recent or planned orthopedic procedure during the course of the study (eg, spine surgery or under lower limbs) that impairs walking in the 6-minute test evaluation.
  • Acute coronary heart disease or unstable angina in the past 3 months
  • Report of disease of the sinus or atrioventricular node with indication of a pacemaker, but with no intention of implantation.
  • Presence of untreated hypothyroidism or hyperthyroidism.
  • Previous heart, liver or other organ transplant.
  • Presence of neoplasia in the last 3 years, except for basal and squamous cell carcinomas of skin or cervical cancer in situ previously treated.
  • Presence of other medical conditions or comorbidities that, in the investigator's opinion, could interfere with the course of the study or the interpretation of the data.
  • Pregnancy.
  • History of alcohol abuse in the last 2 years or excessive daily alcohol intake (for women, more than 14 units per week; for men, more than 21 units of alcohol per week [unit: one glass of wine (125ml) = one dose of distillate = 332.5ml of beer).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04456582
Other Study ID Numbers  ICMJE 4963/19/182
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Fábio Fernandes, University of Sao Paulo General Hospital
Study Sponsor  ICMJE Fábio Fernandes
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo General Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP