NCT04849754

Brief Summary

Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

4.8 years

First QC Date

April 15, 2021

Last Update Submit

April 17, 2024

Conditions

Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy

    6 months

Study Arms (1)

Patients with transthyretin related cardiac amyloidosis

OTHER

Bone scintigraphy

Diagnostic Test: bone scintigraphy

Interventions

bone scintigraphyDIAGNOSTIC_TEST

Bone scintigraphy

Patients with transthyretin related cardiac amyloidosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient, male or female, over 18 years of age
  • Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy
  • Patient with signed consent

You may not qualify if:

  • Patients with systemic AL amyloidosis
  • Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital privé Le Bois

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Study Officials

  • Fredric MOUQUET

    Hôpital Privé Le Bois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic MOUQUET

CONTACT

0642377375fmouquet@ovh.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 19, 2021

Study Start

February 25, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)