Autonomic Evaluation of Patients With Hereditary Amyloidotic Cardiomyopathy: Hereditary Amyloidotic Heart Disease
NCT ID: NCT05087953
Last Updated: 2021-10-21
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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UNKNOWN
60 participants
OBSERVATIONAL
2022-01-31
2023-07-31
Brief Summary
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Although a specific mutation usually causes a specific phenotype, that is, with a predominantly cardiac or preferential neurological profile, with the increase in the number of diagnosed cases, an overlapping of clinical presentations has been observed.
The assessment of the autonomic profile in individuals with familial amyloidotic cardiomyopathy (FAC) has not been well studied, and it is not known whether patients with an exclusively cardiac profile of the disease may present dysautonomia or whether even mutation carriers without cardiac involvement may exhibit it.
In this study, the autonomic profiles of patients with familial amyloidotic heart disease will be compared with the profiles of patients who have mutations but without established heart disease and healthy individuals (control group).
Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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FAC group
Patients with familial amyloidotic cardiomyopathy.
Head-Up Tilt table test
Autonomic response assessment in the orthostatic head up tilt test.
Heart Rate Variability
Assessment of heart rate variability on 24-hour Holter monitoring..
Non-FAC group
Patients with transthyretin gene mutations who do not have FAC.
Head-Up Tilt table test
Autonomic response assessment in the orthostatic head up tilt test.
Heart Rate Variability
Assessment of heart rate variability on 24-hour Holter monitoring..
Control group
Healthy subjects.
Head-Up Tilt table test
Autonomic response assessment in the orthostatic head up tilt test.
Heart Rate Variability
Assessment of heart rate variability on 24-hour Holter monitoring..
Interventions
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Head-Up Tilt table test
Autonomic response assessment in the orthostatic head up tilt test.
Heart Rate Variability
Assessment of heart rate variability on 24-hour Holter monitoring..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-FAC group: patients with transthyretin gene mutations who do not have FAC.
* Control group: healthy, asymptomatic individuals without comorbidities and without transthyretin gene mutations.
* Agreement and signing the informed consent form.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Fleury
UNKNOWN
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
University of Sao Paulo Medical School - The Heart Institute
São Paulo, , Brazil
Fabio Fernandes
São Paulo, , Brazil
Countries
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Central Contacts
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References
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Rapezzi C, Quarta CC, Riva L, Longhi S, Gallelli I, Lorenzini M, Ciliberti P, Biagini E, Salvi F, Branzi A. Transthyretin-related amyloidoses and the heart: a clinical overview. Nat Rev Cardiol. 2010 Jul;7(7):398-408. doi: 10.1038/nrcardio.2010.67. Epub 2010 May 18.
Cruz MW. Regional differences and similarities of familial amyloidotic polyneuropathy (FAP) presentation in Brazil. Amyloid. 2012 Jun;19 Suppl 1:65-7. doi: 10.3109/13506129.2012.673183. Epub 2012 Apr 12.
Queiroz MC, Pedrosa RC, Berensztejn AC, Pereira Bde B, Nascimento EM, Duarte MM, Pereira-Junior PP, Cruz MW. Frequency of Cardiovascular Involvement in Familial Amyloidotic Polyneuropathy in Brazilian Patients. Arq Bras Cardiol. 2015 Nov;105(5):503-9. doi: 10.5935/abc.20150112. Epub 2015 Sep 8.
Cruz MW, Foguel D, Berensztejn AC, Pedrosa RC, Mundayat R, Ong ML; THAOS Investigators. The demographic, genetic, and clinical characteristics of Brazilian subjects enrolled in the Transthyretin Amyloidosis Outcomes Survey. Amyloid. 2017 Mar;24(sup1):103-104. doi: 10.1080/13506129.2017.1291423. No abstract available.
Other Identifiers
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SDC 5045/20/074
Identifier Type: -
Identifier Source: org_study_id