Transthyretin AmyloidosisPRATHYCNCT04611204
Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
An observational study of Transthyretin Amyloidosis and Carpal Tunnel Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- What is being tested?
- Descriptive cohort
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 23 Feb 2023
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Interventional transversal monocentric study with prospective recruitment.
Who may be able to join
- Patients over 18 year-old
- Indication carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
- To agree to participate (signature of the informed consent)
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Patients with non-idiopathic carpal tunnel syndrome with medical contraindication : pregnancy, obesity (body mass index > 30), diabetes, rheumatoid arthritis, sarcoidosis, purulent tenosynovitis, tuberculosis, systemic lupus erythematosus, hypothyroidism or hyperthyroidism and gout.
- Patients with history of cardiac disease or coronary artery disease.
- Patients with systemic amyloidosis already known.
- Patients unde guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery
This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.
Read the detailed description
Unrecognized wild-type transthyretin amyloidosis (ATTRwt) in patients with idiopathic carpal tunnel syndrome (CTS) is a prevalent aging-related disorder. Amyloid deposition in the tenosynovial tissue has been reported in ~35% of patients with idiopathic carpal tunnel syndrome.
Otherwise, CTS has been shown to be the most common initial symptom of systemic wild-type transthyretin amyloidosis. The clinical significance of subclinical ATTRwt deposits in the heart in elderly patients has yet to be determined, but these deposits could contribute to the development of heart failure with preserved ejection fraction. ATTRwt has been reported in ~15% of patients with heart failure with preserved ejection fraction. Early detection of amyloid deposition in the transverse carpal ligament of patients with CTS could anticipate cardiac damage and progression to heart failure.The aim of this study is to determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome.
- Conditions
- Transthyretin Amyloidosis, Carpal Tunnel Syndrome
- Being tested
- Descriptive cohort
- Keywords
- cardiac amyloidosis, transthyretin amyloidosis, carpal tunnel syndrome
- Medical subject headings
- Amyloidosis, Hereditary, Transthyretin-Related, Carpal Tunnel Syndrome, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive cohortOther
NT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac involvement
Prevalence of cardiac involvement in presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.
Measured: 1 day
Secondary outcomes (1)
Transthyretin amyloid involvement
Prevalence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released. Electrocardiographic features of cardiac involvement in case of presence of transthyretin amyloid deposition in the transverse carpal ligament of patients with CTS referred for surgery released.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Oct 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin AmyloidosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier LAIREZ, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611204
- Sponsor's protocol ID
- RC31/18/0470
- Acronym
- PRATHYC
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No