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Autonomic Evaluation of Patients With Hereditary Amyloidotic Cardiomyopathy: Hereditary Amyloidotic Heart Disease

NCT05087953 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-10-21

No results posted yet for this study

Summary

Transthyretin amyloidosis exhibits a variety of possible phenotypes, the hereditary neurological form being the most commonly found and studied (familial amyloidotic polyneuropathy or FAP), which can present from oligosymptomatic patients to patients with peripheral sensorimotor polyneuropathy of varying degrees and dysautonomia.

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).

Conditions

  • Autonomic Nervous System Disease
  • Amyloid Neuropathies

Interventions

DIAGNOSTIC_TEST

Head-Up Tilt table test

Autonomic response assessment in the orthostatic head up tilt test.

DIAGNOSTIC_TEST

Heart Rate Variability

Assessment of heart rate variability on 24-hour Holter monitoring..

Sponsors & Collaborators

  • Fleury

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-01-31
Completion
2023-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087953 on ClinicalTrials.gov