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

Primary Purpose

Amyloidosis, Cardiac Amyloidosis, Olfactory Loss

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sniffin's stick test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Amyloidosis focused on measuring Amyloidosis, cardiac amyloidosis, olfactory loss, hyposmia, dysosmia, smell disorders, taste disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Test de bâton de Sniff

Arm Description

Cohorte

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
TDI scores of Sniffin's stick test compared to Sniffin's stick test TDI scores of age and gender-matched subjects
correlation between type of amyloidosis (AL, TTR mutated and wild type) and Sniffin's stick test TDI's score (/48)
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
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

Full Information

First Posted
November 19, 2020
Last Updated
March 8, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04661800
Brief Title
Study of Olfactory Disorders in Patients With Cardiac Amyloidosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis, Cardiac Amyloidosis, Olfactory Loss, Hyposmia, Dysosmia, Smell Disorders, Taste Disorders
Keywords
Amyloidosis, cardiac amyloidosis, olfactory loss, hyposmia, dysosmia, smell disorders, taste disorders

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test de bâton de Sniff
Arm Type
Other
Arm Description
Cohorte
Intervention Type
Other
Intervention Name(s)
Sniffin's stick test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis
Time Frame
at inclusion day
Title
Severity of smell and taste disorders in a population of patients with cardiac amyloidosis, evaluated with Sniffin's stick tests score (score/48)
Time Frame
at inclusion day
Secondary Outcome Measure Information:
Title
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
Time Frame
at inclusion day
Title
TDI scores of Sniffin's stick test compared to Sniffin's stick test TDI scores of age and gender-matched subjects
Time Frame
at inclusion day
Title
correlation between type of amyloidosis (AL, TTR mutated and wild type) and Sniffin's stick test TDI's score (/48)
Time Frame
at inclusion day
Title
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
Time Frame
at inclusion day
Title
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
Time Frame
at inclusion day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Bartier, MD
Phone
+33 1 49 81 24 91
Email
sophie.bartier@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dalila Selmane
Phone
+33149813344
Email
dalila.selmane@aphp.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
City
Créteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Learn more about this trial

Study of Olfactory Disorders in Patients With Cardiac Amyloidosis

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