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

Amyloid Cardiomyopathy Clinical Trial

— ATTRAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699044
• Other study ID #: 1-10-72-53-22
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: May 2023
• Source: Aarhus University Hospital Skejby
• Contact: Jens Skov, MD
• Phone: 2074381
• Email: jesmds[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: October 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloid Cardiomyopathy
• Cardiomyopathies

Intervention

Diagnostic Test:
• Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)
Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent. DPD-scintigraphy. (Echocardiography)

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Steen Hvitfeldt Poulsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical Stage of time of diagnosis in patients with ATTRwt	Gilmore Staging	3 years
Secondary	Number of heart-failure associated hospitalization among ATTRwt patients		5 years
Secondary	All-cause mortality among ATTRwt patients.		5 year