ATTR Cardiac Amyloidosis in a Selected Population | NCT06458374

Studies
ATTR Cardiac Amyloidosis in a Selected Population

NCT06458374

Sponsor

Helse Møre og Romsdal HF

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

ATTR Amyloidosis Wild Type
ATTR Gene Mutation
Carpal Tunnel Syndrome
Cardiac Amyloidosis

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Feb 28, 2034Estimated

Completion Date

Feb 28, 2039Estimated

First Submitted Date

Jun 7, 2024

First Submission Date that Met QC Criteria

Jun 10, 2024

First Posted Date

Jun 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.

Detailed Description

Biopsy proven ATTR (v/wt) amyloidosis inpatients operated with CTS will undergo standard guidelines recommended examinations as 99mTcDPD SPECT CT, echocardiography, ECG, Holter, genetic testing (v/wt), and lab testing, and CMRI as indicated. Exclusion of light chain disease will be done.

All patients will be followed at least yearly as indicated by guidelines (ESC), and patients with development of cardiac amyloidosis will get standard treatment in accordance with guidelines and as approved by the Norwegian government. All patients will be followed for 10 years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of ATTR in CTS	Biopsy proven ATTR	2 years
Cardiac involvement in patients with biopsy proven ATTR	Scintigraphic and echocardiographic cardiac involvement possibly cMRI	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male > 50 years
Female > 60 years
operated CTS at Ålesund Hospital

Exclusion Criteria:

not consented
do not speak Norwegian
secondary cause of CTS as traumatic or rheumatic
cannot be followed > 5 years due to other medical conditions
Cardiac disease at time of operation for CTS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Maximum 200 patients operated at Ålesund Hospital for CTS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Torstein Hole, Professor, MD, PhD	Contact	+4770105000, +4793421002		torstein.hole@helse-mr.no
Jørn A Lillebø, consultant cardiology, MD	Contact	+4770105000		jorn.asle.lillebo@helse-mr.no

Overall Officials

Name	Affiliation	Role
Torstein Hole, MD, PhD	Helse Møre og Romsdal HF and NTNU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ålesund Hospital	Recruiting	Ålesund	Møre og Romsdal	6026	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome
D028227	Amyloid Neuropathies, Familial

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

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Browse Branches

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