Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
|ClinicalTrials.gov Identifier: NCT01477658|
Recruitment Status : Unknown
Verified May 2013 by Roberto Costa, University of Sao Paulo.
Recruitment status was: Enrolling by invitation
First Posted : November 22, 2011
Last Update Posted : May 7, 2013
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown.
Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.
|Condition or disease|
|Congenital Complete Atrioventricular Heart Block High Grade Atrioventricular Block Postoperative Complete Heart Block|
This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB.
The design of the study will involve the following stages:
- Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;
- Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;
- Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
- Follow-up: patients will be monitored during 24 months.
The main end-points are:
- Clinical and functional changes (NYHA functional class)
- Heart failure hospitalization
- Quality of life
- Overall and cardiac mortality
- Cardiac resynchronization therapy and heart transplantation
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block|
|Study Start Date :||November 2007|
|Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2013|
Congenital AV Block
Patients diagnosed with Congenital Complete Atrioventricular Heart Block
Postoperative AV Block
Patients diagnosed with postoperative AV block
- Mortality [ Time Frame: 24 months after enrollment ]
- Echocardiogram and Clinical Composite [ Time Frame: baseline and 24 months after enrollment ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477658
|Heart Institute (InCor) of University of São Paulo Medical School (Brazil)|
|Sao Paulo, Brazil, 05403000|
|Study Chair:||Roberto Costa, MD, PhD||University of Sao Paulo|
|Principal Investigator:||Roberto M Oliveira Jr, MD||University of Sao Paulo|