Clinical trial NCT01477658: Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Official title: Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Complete Atrioventricular Heart Block
High Grade Atrioventricular Block
Postoperative Complete Heart Block
Keywords: Congenital Complete Atrioventricular Heart Block
Pacemaker
Cardiac pacing
Children
Heart failure
Ventricular dyssynchrony
Echocardiography
Quality of life
Six-minute walk test
Young adults
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory Care

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Echocardiogram and Clinical Composite
timeFrame: baseline and 24 months after enrollment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) of University of São Paulo Medical School (Brazil)
Study officials:
affiliation: University of Sao Paulo
name: Roberto Costa, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Roberto M Oliveira Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: