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

NCT ID: NCT05699044

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyloid Cardiomyopathy Block, AV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amyloidosis Screening

Patients fulfilling eligibility criteria will screened for Cardiac Amyloidosis.

Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)

Intervention Type DIAGNOSTIC_TEST

Bloodtest: Troponin I, NT-pro-BNP, electrolyte status, renal function, kampda/lambda free chain + ratio, M-komponent.

DPD-scintigraphy. (Echocardiography)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Steen Hvitfeldt Poulsen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Steen Hvitfeldt Poulsen

Prof. Poulsen

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steen Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cardiology, Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jens Skov, MD

Role: CONTACT

2074381 ext. +45

Steen Poulsen, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jens Skov, MD

Role: primary

20749381 ext. +45

Steen Poulsen, MD

Role: backup

30922309 ext. +45

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-53-22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Arrhythmia Prediction Trial
NCT02175836 UNKNOWN
Clinical Cohort Study - TRUST
NCT05521451 RECRUITING
Short Atrioventricular Delay Pacing
NCT01233661 WITHDRAWN NA
Ablation at Virtual-hEart pRedicted Targets for VT
NCT03536052 ACTIVE_NOT_RECRUITING NA