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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05699044
Acronym
ATTRAB
Enrollment
170
Registered
2023-01-26
Start date
2022-10-01
Completion date
2025-10-01
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid Cardiomyopathy, Block, AV

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.

Interventions

DIAGNOSTIC_TESTAmyloidosis 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)

Sponsors

Steen Hvitfeldt Poulsen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of ATTRwt in study cohort.3 yearsNumber of participants with a diagnosis of ATTRwt in the study cohort based on DPD-scintigraphy or if necessary, a cardiac biopsy.

Secondary

MeasureTime frameDescription
Number of heart-failure associated hospitalization among ATTRwt patients5 years
All-cause mortality among ATTRwt patients.5 year
Clinical Stage of time of diagnosis in patients with ATTRwt3 yearsGilmore Staging
Characteristics of patients with ATTRwt3 yearsEchocardiographic (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

Countries

Denmark

Contacts

Primary ContactJens Skov, MD
jesmds@rm.dk2074381
Backup ContactSteen Poulsen, MD
steenhvitfeldtpoulsen@gmail.com30922309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026