AmyloidosisAMYLODORNCT04661800
Study of Olfactory Disorders in Patients With Cardiac Amyloidosis
A study testing Sniffin's stick test in people with Amyloidosis and Cardiac Amyloidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis, Cardiac Amyloidosis, Olfactory Loss
- What is being tested?
- Sniffin's stick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2021to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 11Show fewer
- Antecedent of ENT radiotherapy
- History of chemotherapy
- Patient under guardianship, curatorship or legal protection
- Patient on AME
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
About this study
Official title: 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).
Read more
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
- Being tested
- Sniffin's stick test
- Keywords
- Amyloidosis, cardiac amyloidosis, olfactory loss, hyposmia, dysosmia, smell disorders, taste disorders
- Medical subject headings
- Amyloidosis, Amyloid Neuropathies, Familial, Anosmia, Olfaction Disorders, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffin's stick testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test de bâton de Sniff | Other | Cohorte Receives: Other: Sniffin's stick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis
Measured: 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)
Measured: 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
Measured: at inclusion day
TDI scores of Sniffin's stick test compared to Sniffin's stick test TDI scores of age and gender-matched subjects
Measured: at inclusion day
correlation between type of amyloidosis (AL, TTR mutated and wild type) and Sniffin's stick test TDI's score (/48)
Measured: 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
Measured: 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
Measured: at inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start22 Mar 2021
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661800
- Sponsor's protocol ID
- APHP200835
- Acronym
- AMYLODOR
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2020
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Alterations in Olfactory and Taste Function in Patients With Cardiac Amyloidosis and Nutritional Impact: Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04661800
- Acronym / sponsor ID
- AMYLODOR / APHP200835
- Conditions
- Amyloidosis, Cardiac Amyloidosis, Olfactory Loss, Hyposmia, Dysosmia, Smell Disorders
- Keywords
- Amyloidosis, cardiac amyloidosis, olfactory loss, hyposmia, dysosmia, smell disorders, taste disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test de bâton de Sniff | Other | Other: Sniffin's stick testCohorte |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sniffin's stick testThe 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. | Other | Test de bâton de Sniff |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Related trials for Amyloidosis
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sniffin's stick test in people with Amyloidosis and Cardiac Amyloidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of smell and taste disorders in a population of patients with cardiac amyloidosis (time frame: at inclusion day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.