- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661800
Study of Olfactory Disorders in Patients With Cardiac Amyloidosis (AMYLODOR)
Prevalence and Characteristics of Alterations in Olfactory and Taste Function in Patients With Cardiac Amyloidosis and Nutritional Impact: Multicenter Cross-sectional Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie Bartier, MD
- Phone Number: +33 1 49 81 24 91
- Email: sophie.bartier@aphp.fr
Study Contact Backup
- Name: Dalila Selmane
- Phone Number: +33149813344
- Email: dalila.selmane@aphp.fr
Study Locations
-
-
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Créteil, France, 94010
- Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Test de bâton de Sniff
Cohorte
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis
Time Frame: at inclusion day
|
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)
Time Frame: at inclusion day
|
at inclusion day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at inclusion day
|
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
|
at inclusion day
|
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
|
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
Time Frame: at inclusion day
|
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
Time Frame: at inclusion day
|
at inclusion day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP 200835
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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