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

May 4, 2013 updated by: Roberto Costa, University of Sao Paulo

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Heart Institute (InCor) of University of São Paulo Medical School (Brazil)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Ambulatory Care

Description

Inclusion Criteria:

  • Age <18 years at initial pacemaker implantation
  • Advanced AV block with /without congenital heart defects
  • Time under cardiac pacing superior than one year
  • Unicameral or atrioventricular pacing in single right ventricle site
  • Informed consent of the patient or responsible

Exclusion Criteria:

  • Bifocal or biventricular pacing
  • Discontinuing use of the device for recovery of atrioventricular conduction
  • Cardiac transplantation
  • Inability to participate in the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Congenital AV Block
Patients diagnosed with Congenital Complete Atrioventricular Heart Block
Postoperative AV Block
Patients diagnosed with postoperative AV block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 24 months after enrollment
24 months after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Echocardiogram and Clinical Composite
Time Frame: baseline and 24 months after enrollment
baseline and 24 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Roberto Costa, MD, PhD, University of Sao Paulo
  • Principal Investigator: Roberto M Oliveira Jr, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 4, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq nº 1248/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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