Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation

Study Overview
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Brief Summary
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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.

Official Title
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Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study

Conditions
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Block, AV, Amyloid Cardiomyopathy

Intervention / Treatment
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* Diagnostic Test: Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm. Exclusion Criteria: Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery <1month, endocarditis.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amyloidosis Screening<br>Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis. | Diagnostic Test: Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)<br>* Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent. DPD-scintigraphy. (Echocardiography)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients with ATTRwt | Echocardiographic (Left ventricular (LV) wall thickness, LV cavity dimension, EF, GLS, diastolic function, Right Ventricular (RV) systolic function, valve disease) Biochemical profile (Troponin I, NT-pro-BNP, Renal Function (E-GFR) ), presence or history of spinal stenosis, carpal tunnel syndrome | 3 years | 
| Clinical Stage of time of diagnosis in patients with ATTRwt | Gilmore Staging | 3 years | 
| Number of heart-failure associated hospitalization among ATTRwt patients |  | 5 years | 
| All-cause mortality among ATTRwt patients. |  | 5 year |