Clinical Trial: Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Brief Summary:

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.


Detailed Summary:

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:

  1. 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;
  2. 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;
  3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
  4. 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

Sponsor: University of Sao Paulo

Current Primary Outcome: Mortality [ Time Frame: 24 months after enrollment ]

Original Primary Outcome:

Current Secondary Outcome: Echocardiogram and Clinical Composite [ Time Frame: baseline and 24 months after enrollment ]

Original Secondary Outcome:

Information By: University of Sao Paulo

Dates:
Date Received: November 18, 2011
Date Started: November 2007
Date Completion: November 2013
Last Updated: May 4, 2013
Last Verified: May 2013