Study of Olfactory Disorders in Patients With Cardiac Amyloidosis

Amyloidosis Clinical Trial

— AMYLODOR  

Official title:

Prevalence and Characteristics of Alterations in Olfactory and Taste Function in Patients With Cardiac Amyloidosis and Nutritional Impact: Multicenter Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04661800
• Other study ID #: APHP 200835
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sophie Bartier, MD
• Phone: +33 1 49 81 24 91
• Email: sophie.bartier[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis
• Disease
• Dysosmia
• Hyposmia
• Olfaction Disorders
• Olfactory Loss
• Smell Disorders
• Taste Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis		at inclusion day
Primary	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	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
Secondary	TDI scores of Sniffin's stick test compared to Sniffin's stick test TDI scores of age and gender-matched subjects		at inclusion day
Secondary	correlation between type of amyloidosis (AL, TTR mutated and wild type) and Sniffin's stick test TDI's score (/48)		at inclusion day
Secondary	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
Secondary	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