Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients \> 18 years diagnosed with ATTRwt-CM by:

• endomyocardial biopsy

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

• Informed oral and written consent

• Patients \> 18 years

• Informed oral and written consent

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Sie Kronborg Fensman, MD
siefensman@gmail.com
+45 30 48 88 85
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
wtATTR-CM patients (n = 100)
Clinical history, physical examination, ECG, advanced echocardiography, blood and urine samples, cardiac magnetic resonance imaging (CMRI), and QoL questionaires (KCCQ, EQ-5Q-5L and ATTR-QoL)).~Subgroup with these patient (n = 10): A endomyocardial biopsy.
Control (n = 20)
Blood and urine samples. To rule out cardiac disease: clinical history, physical examination, ECG and advanced echocardiography.
Related Therapeutic Areas
Transthyretin Amyloid Cardiomyopathy
Cardiomyopathy
Transthyretin Amyloidosis
Primary Amyloidosis
Sponsors
Collaborators: Novo Nordisk A/S
Leads: Steen Hvitfeldt Poulsen

This content was sourced from clinicaltrials.gov

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