An interventional study of Sniffin's stick test in Amyloidosis, Cardiac Amyloidosis and Olfactory Loss, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Screening
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.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's enrollment of 51 is above the median of 46 across 189 interventional studies indexed under Amyloidosis.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohorte
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.
Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis
Time frame: 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
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
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
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
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
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
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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