Study of Olfactory Disorders in Patients With Cardiac Amyloidosis

NCT04661800 | Completed

• 1 other identifier: APHP200835
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Amyloidosis; cardiac amyloidosis; olfactory loss; hyposmia; dysosmia; smell disorders; taste disorders

Outcome Measures

Primary Outcomes (2)

• Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis

  at inclusion day

• Severity of smell and taste disorders in a population of patients with cardiac amyloidosis, evaluated with Sniffin's stick tests score (score/48)

  at inclusion day

Secondary Outcomes (5)

• Date of onset of smell and taste disorder (month/years) compared with date of onset of cardiological symptoms and cardiac amyloidosis, based on declarative assessment

  at inclusion day

• TDI scores of Sniffin's stick test compared to Sniffin's stick test TDI scores of age and gender-matched subjects

  at inclusion day

• correlation between type of amyloidosis (AL, TTR mutated and wild type) and Sniffin's stick test TDI's score (/48)

  at inclusion day

• Correlation between severity of cardiac amyloidosis and and Sniffin's stick test TDI's score (/48). Severity of cardiac amyloidosis is evaluated by clinical characteristics (NYHA, Heart rate (bpm), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure

  at inclusion day

• Correlation between nutritional depletion and Sniffin's stick test TDI scores (/48). Nutritional depletion is evaluated by BMI (Body mass index kg/m2), brachial circumference (cm), tricipital fold (mm), orosomucoid g/L

  at inclusion day

Study Arms (1)

Test de bâton de Sniff

OTHER

Cohorte

Other: Sniffin's stick test

Interventions

Sniffin's stick test 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.

Test de bâton de Sniff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Conditions

Amyloidosis; Amyloid Neuropathies, Familial; Anosmia; Olfaction Disorders; Taste Disorders

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model description: 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. All subjects will have an ENT check-up including: an ENT examination with a nasal endoscopy, an evaluation of the olfactory function by Sniffin's stick tests (test which consists of smelling smelling pens) an evaluation of taste (test which consists of discriminating between acid, bitter, sweet and salty using blotting papers placed on the tongue). Nutritional status will be assessed by a mini-questionnaire, measurement of weight, brachial circumference and tricipital skin fold, calculation of body mass index (BMI), orosomucoid dosage.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 10, 2020
• Study Start: March 22, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)