Study of Olfactory Disorders in Patients With Cardiac Amyloidosis

NCT ID: NCT04661800

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2022-12-01

Brief Summary

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.

Conditions

Amyloidosis; Cardiac Amyloidosis; Olfactory Loss; Hyposmia; Dysosmia; Smell Disorders; Taste Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Test de bâton de Sniff

Cohorte

Group Type: OTHER

Sniffin's stick test

Intervention Type: OTHER

The sniffin's stick test is a three-part test consisting of smelling odor pens: 1) determining a detection threshold, 2) discriminating ability, 3) ability to identify odors. It lasts about 30 minutes, is achievable in the room.

Interventions

Sniffin's stick test

The sniffin's stick test is a three-part test consisting of smelling odor pens: 1) determining a detection threshold, 2) discriminating ability, 3) ability to identify odors. It lasts about 30 minutes, is achievable in the room.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, , France

Countries

France

Central Contacts

Sophie Bartier, MD

Role: CONTACT

sophie.bartier@aphp.fr

+33 1 49 81 24 91

Dalila Selmane

Role: CONTACT

dalila.selmane@aphp.fr

+33149813344

Other Identifiers

APHP 200835

Identifier Type: -

Identifier Source: org_study_id