Phenotyping and Characterization of wtATTR-CM (TRACE 1)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSteen Hvitfeldt Poulsen

About this trial

Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.

Eligibility criteria

Qualifiers

endomyocardial biopsy

DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing.

Informed oral and written consent

Disqualifiers

AL amyloidosis (light-chain amyloidosis).

Myelomatosis

Waldenström macroglobulinemia

Patients > 18 years

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

120 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Steen Hvitfeldt Poulsen

Lead sponsor

Aarhus University Hospital Skejby

Sponsor institution

Novo Nordisk A/S

Collaborator