Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation
ATTRAB
Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study
1 other identifier
observational
170
1 country
1
Brief Summary
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJune 2, 2023
May 1, 2023
2.8 years
October 4, 2022
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnosis of ATTRwt in study cohort.
Number of participants with a diagnosis of ATTRwt in the study cohort based on DPD-scintigraphy or if necessary, a cardiac biopsy.
3 years
Secondary Outcomes (4)
Characteristics of patients with ATTRwt
3 years
Clinical Stage of time of diagnosis in patients with ATTRwt
3 years
Number of heart-failure associated hospitalization among ATTRwt patients
5 years
All-cause mortality among ATTRwt patients.
5 year
Study Arms (1)
Amyloidosis Screening
Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis.
Interventions
Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent. DPD-scintigraphy. (Echocardiography)
Eligibility Criteria
Patients admitted for pacemakerimplantation with advanced AV-block fulfilling eligibility criteria as described.
You may qualify if:
- Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm.
You may not qualify if:
- Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery \<1month, endocarditis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Aarhus University Hospital
Aarhus, 8200, Denmark
Biospecimen
Bloodtest
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steen Poulsen, MD
Department of Cardiology, Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Poulsen
Study Record Dates
First Submitted
October 4, 2022
First Posted
January 26, 2023
Study Start
October 1, 2022
Primary Completion
August 1, 2025
Study Completion
October 1, 2025
Last Updated
June 2, 2023
Record last verified: 2023-05