Risk of Pacing-induced Cardiomyopathy

Status Completed

Clinical Trial Summary

This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.

Clinical Trial Description

Background: Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssynchronous electrical and mechanical activation of the myocardium. The activation is affected by the RV pacing site. Understanding the consequences of different RV pacing sites and the patterns of dyssynchrony may help to choose the optimal treatment for the individual patient. Aim and objectives: The overall aim of this project is to investigate the association between RV pacing site and the risk of PICM. Contrast enhanced cardiac computed tomography (CT) will be applied for precise localization of the RV pacing. Furthermore, investigation of the association between PICM and different mechanical and electrical myocardial activation patterns during RV pacing will be conducted using new echocardiographic and electrocardiographic methods. Methods: The study is designed as a retrospective cohort study with clinical follow-up. Patients with prior pacemaker implantation due to advanced atrioventricular block will be included. The study baseline is retrospective and defined as time of pacemaker implantation and follow-up is time of inclusion. Baseline data will be extracted from the Danish Pacemaker- and ICD Registry, electronic medical records (EMR) and review of echocardiographs. Follow-up data will be extracted from existing data in the EMRs as well as generated during a follow-up visit with a clinical examination. For assessment of cardiac function, RV lead position and electrical and mechanical activations patterns, the examination will include a transthoracic echocardiography, an electrocardiogram, a 3-dimensional chest photo, and a contrast-enhanced cardiac CT. Data will be analysed for differences between those who develop PICM and those who do not. Expected outcomes and perspectives: The hope is that this project will generate knowledge and awareness on pacemaker treatment and the risk of PICM. Understanding the pathophysiology behind PICM is key to learning how to prevent it. Accordingly, this project has the potential to contribute to improving pacemaker treatment and the quality of care for the large and still growing PM population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04269733
Study type	Observational
Source	Aalborg University Hospital
Contact
Status	Completed
Phase
Start date	May 1, 2020
Completion date	August 1, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.