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

Recruiting

• Conditions: Block, AV; Amyloid Cardiomyopathy
• Interventions: Diagnostic Test: Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)

• Registration Number: NCT05699044
• Lead Sponsor: Steen Hvitfeldt Poulsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02
• Primary Completion: 2025-08-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amyloidosis Screening	Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)	Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis.

Primary Outcome Measures

Name	Time	Method
Diagnosis of ATTRwt in study cohort.	3 years	Number of participants with a diagnosis of ATTRwt in the study cohort based on DPD-scintigraphy or if necessary, a cardiac biopsy.

Secondary Outcome Measures

Name	Time	Method
Characteristics of patients with ATTRwt	3 years	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
Clinical Stage of time of diagnosis in patients with ATTRwt	3 years	Gilmore Staging
Number of heart-failure associated hospitalization among ATTRwt patients	5 years
All-cause mortality among ATTRwt patients.	5 year

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark