Comprehensive Program for Hereditary Transthyretin Amyloidosis
NCT ID: NCT07213297
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-10-01
2028-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants over 18 years of age diagnosed with hereditary transthyretin amyloidosis
Participants with a pathogenic variant of the TTR gene confirmed by genetic testing, whether symptomatic and/or with suspected disease progression, as well as asymptomatic carriers of these variants, will be included. Individuals with wild-type TTR amyloidosis will be excluded .
clinical assessments and complementary examinations
Evaluation Plan
Comprehensive Examination: Complete medical history and physical examination of all body systems, including height and weight measurements.
Clinical Parameters: Pulse/heart rate, respiratory rate, and SpO2 will be monitored. The NYHA classification will be used to assess heart failure if applicable.
Neurological Examination: Includes motor strength testing, sensory testing (pinprick, light touch, temperature, proprioception), deep tendon reflexes, and gait assessment.
Electrocardiogram (ECG): A 12-lead ECG will be performed with the subject at rest for at least 5 minutes in a supine position.
24-hour Holter Monitoring: Conducted in cases of suspected arrhythmias or echocardiographic findings indicating arrhythmias.
Color Dosments and complementary examinations
Interventions
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clinical assessments and complementary examinations
Evaluation Plan
Comprehensive Examination: Complete medical history and physical examination of all body systems, including height and weight measurements.
Clinical Parameters: Pulse/heart rate, respiratory rate, and SpO2 will be monitored. The NYHA classification will be used to assess heart failure if applicable.
Neurological Examination: Includes motor strength testing, sensory testing (pinprick, light touch, temperature, proprioception), deep tendon reflexes, and gait assessment.
Electrocardiogram (ECG): A 12-lead ECG will be performed with the subject at rest for at least 5 minutes in a supine position.
24-hour Holter Monitoring: Conducted in cases of suspected arrhythmias or echocardiographic findings indicating arrhythmias.
Color Dosments and complementary examinations
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital de Alta Complejidad en Red
OTHER
Responsible Party
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Gisela Mariel Zanga
PRINCIPAL INVESTIGATOR
Locations
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Hospital Cuenca Alta de Cañuelas
Cañuelas, Buenos Aires, Argentina
Countries
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Central Contacts
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References
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Pinto MV, Barreira AA, Bulle AS, Freitas MRG, Franca MC Jr, Gondim FAA, Marrone CD, Marques W Jr, Nascimento OJM, Rotta FT, Pupe C, Waddington-Cruz M. Brazilian consensus for diagnosis, management and treatment of transthyretin familial amyloid polyneuropathy. Arq Neuropsiquiatr. 2018 Sep;76(9):609-621. doi: 10.1590/0004-282X20180094.
Other Identifiers
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ESCAN
Identifier Type: -
Identifier Source: org_study_id
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