An observational study in Amyloid Cardiomyopathy and Block, AV, sponsored by Steen Hvitfeldt Poulsen. Recruiting at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Steen Hvitfeldt Poulsen · Observational
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 170 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Steen Hvitfeldt Poulsen is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted for pacemakerimplantation with advanced AV-block fulfilling eligibility criteria as described.
Exclusion Criteria:
Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis.
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)
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.
Time frame: 3 years
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
Time frame: 3 years
Clinical Stage of time of diagnosis in patients with ATTRwt
Gilmore Staging
Time frame: 3 years
Number of heart-failure associated hospitalization among ATTRwt patients
Time frame: 5 years
All-cause mortality among ATTRwt patients.
Time frame: 5 year
Plan to share: Undecided
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Steen Hvitfeldt Poulsen