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Study of Olfactory Disorders in Patients With Cardiac Amyloidosis (AMYLODOR)

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Cardiac Amyloidosis
Dysosmia
Hyposmia
Amyloidosis
Olfactory Loss
Taste Disorders
Smell Disorders

Treatments

Other: Sniffin's stick test

Study type

Interventional

Funder types

Other

Identifiers

NCT04661800
APHP 200835

Details and patient eligibility

About

Amyloidosis is a disease caused by the continuous accumulation of fibrillary proteins in the extracellular matrix causing the architecture of different organs to be disrupted. The prevalence of the disease increases with age. The two most common forms are light chain amyloidosis (AL) and transthyretin (TTR). TTR amyloidosis may be hereditary (m-TTR, or mutated) or age-related (WT-TTR, or wild). The latter is also called senile amyloidosis. In all these forms, cardiac impairment is common and leads the patient to consult/or be referred to a cardiological center unfortunately often too late when the prognosis is directly related to the severity of the heart attack. The description/discovery of clinical signs prior to heart disease is important to improve the detection and diagnosis of early forms of cardiac amyloidosis (CA). For example, an infiltration of the carpal tunnel synovial by amyloid deposits is observed in some patients, 5 years before the onset of signs of heart failure and is the only warning sign of the disease known to date. We also showed in a previous study that patients had more severe and earlier impairment of hearing function than expected by age and gender.

Objective The main objective is to define the prevalence and severity of smell and taste disorders in a population of patients with cardiac amyloidosis (3 types of mutated or wild AL amyloidosis and TTR).

The main endpoint is to determine the number of patients with impaired smell and taste's functions in a population of patients diagnosed with cardiac amyloidosis (3 types of mutated (hereditary) or senile wild amyloidosis (3 types of AL amyloidosis and TTR).

Method Successive monocentric cross-sectional study on the screening of smell and taste disorders carried out as part of a cardiology hospitalization programmed for the cardiology follow-up of his pathology in a population of patients diagnosed with AC.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age>18 years
  • Affiliated with Social Security
  • Patient who was informed of the study and signed a free and informed consent
  • Patients diagnosed with AC

Exclusion criteria

    • Refusal to participate in the study
  • Patient who does not speak or understand French
  • History of chronic rhino sinusitis with or without polyps
  • A history of counter-indicating the completion of nasal endoscopy (repeated epistaxis, obstructive naso-sinusal tumors, choanal imperforation)
  • History of major craniofacial trauma resulting in loss of smell
  • Known history of Parkinson's disease or Alzheimer's disease
  • Antecedent of ENT radiotherapy
  • History of chemotherapy
  • Patient under guardianship, curatorship or legal protection
  • Patient on AME
  • Pregnant or lactating women

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 1 patient group

Test de bâton de Sniff
Other group
Description:
Cohorte
Treatment:
Other: Sniffin's stick test

Trial contacts and locations

1

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Central trial contact

Dalila Selmane; Sophie Bartier, MD

Data sourced from clinicaltrials.gov

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