Investigating Transthyretin Amyloidosis in Older Patients with AV-Block Undergoing Pacemaker Implantation
Prevalence, Characteristics and Prognosis of Transthyretin Amyloidosis in Patients With New-onset Advanced AV-block - A National Screening Study
This study is testing how common a heart condition called Transthyretin Amyloidosis is in older patients with certain heart issues who need a pacemaker, by using different tests to find out more about the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05699044 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients aged 65 and older who have left ventricular hypertrophy and present with high degree atrioventricular block requiring pacemaker implantation. The investigators will conduct screenings using blood tests, DPD-scintigraphy, and potentially endomyocardial biopsy to identify ATTRwt cases. The study will compare the disease stage of patients diagnosed with ATTRwt through screening to those diagnosed through routine clinical methods.
Who should consider this trial
Good fit: Ideal candidates are men aged 65 and older or women aged 75 and older with unexplained AV-block and left ventricular hypertrophy.
Not a fit: Patients with reversible causes for AV-block or recent heart surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of ATTRwt in older patients with AV-block.
How similar studies have performed: While this approach is novel in this specific patient population, similar studies have shown success in identifying ATTRwt in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus
- Department of Cardiology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Steen Poulsen, MD — Department of Cardiology, Aarhus University Hospital
- Study coordinator: Jens Skov, MD
- Email: jesmds@rm.dk
- Phone: 2074381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.