Increasing Amyloidosis Awareness and Diagnosis Through Programmatic Imaging, Blood/Urine Testing and Pathology

NCT04983433 | Unknown

• 1 other identifier: Amyloidosis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To set up a Brazilian strategy for early diagnosis of cardiac amyloidosis using new modality of echocardiography, the 3D echocardiography, and the level of myocardial deformity by measuring the Strain Longitudinal through the technology Speckle Tracking.

Conditions

Amyloidosis

Keywords

Amyloid cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Number of participants with diagnosis of ATTR cardiac amyloidosis after performing protocol exams (not necessarily all) - echocardiogram, cardiac magnetic resonance, scintigraphy, genetic test, blood and urine paraprotein test and biopsies.

  Infiltrative cardiomyopathy caused by extracellular deposition of insoluble transthyretin amyloid fibrils in the myocardium.

  After performing protocol exams, which will occur, for each patient, approximately, two months after entry in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure in the aged population. Approximately 100 patients will be screened on the patient population described.

You may qualify if:

• Individuals with heart failure in the absence of hypertension
• heart failure with normal ejection fraction
• heart failure associated with aortic stenosis and atypical arrythmias, in which there is the suspicion of cardiaca amyloidosis

You may not qualify if:

• Individuals which do not consent to participate on the study or those that retired the consent during the study
• Individuals under 18 years old

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: lead

Study Sites (1)

Gisele Medeiros Bastos

São Paulo, São Paulo, Brazil

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood

MeSH Terms

Conditions

Amyloidosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Study Officials

• Phillip Scheinberg, MD

  Beneficência Portuguesa de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip Scheinberg, MD

CONTACT

+55 11 3505722; naipe@bp.org.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 30, 2021
• Study Start: August 5, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-07

Locations

BR (1)