Congenital Complete Atrioventricular Heart BlockNCT01477658
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
An observational study of Congenital Complete Atrioventricular Heart Block and High Grade Atrioventricular Block, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ambulatory Care
Who may be able to join
- 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
Who cannot join
- Bifocal or biventricular pacing
- Discontinuing use of the device for recovery of atrioventricular conduction
- Cardiac transplantation
- Inability to participate in the study procedures
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) of University of São Paulo Medical School (Brazil)
São Paulo, São Paulo, 05403000
About this study
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.
Read the 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:
- 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
- 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
- Medical subject headings
- Congenital heart block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Congenital AV Block | Patients diagnosed with Congenital Complete Atrioventricular Heart Block | |
| Postoperative AV Block | Patients diagnosed with postoperative AV block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 24 months after enrollment
Secondary outcomes (1)
Echocardiogram and Clinical Composite
Measured: baseline and 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Complete Atrioventricular Heart BlockStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Costa, University of Sao Paulo
- Investigators
- Roberto Costa, MD, PhD, Study chair, University of Sao PauloRoberto M Oliveira Jr, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477658
- Sponsor's protocol ID
- CAPPesq nº 1248/09
- Status last verified
- May 2013
- First submitted
- 18 Nov 2011
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
- ClinicalTrials.gov ID
- NCT01477658
- Acronym / sponsor ID
- CAPPesq nº 1248/09
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital AV Block | – | –Patients diagnosed with Congenital Complete Atrioventricular Heart Block |
| Postoperative AV Block | – | –Patients diagnosed with postoperative AV block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ambulatory Care
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Bifocal or biventricular pacing
- Discontinuing use of the device for recovery of atrioventricular conduction
- Cardiac transplantation
- Inability to participate in the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 24 months after enrollment
1 secondary outcome
Echocardiogram and Clinical Composite
Time frame: baseline and 24 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Costa, MD, PhD study chair
University of Sao Paulo
Roberto M Oliveira Jr, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Complete Atrioventricular Heart Block and High Grade Atrioventricular Block, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 24 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.