Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
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.
Studieoversigt
Status
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Sao Paulo, Brasilien, 05403000
- Heart Institute (InCor) of University of São Paulo Medical School (Brazil)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Congenital AV Block
Patients diagnosed with Congenital Complete Atrioventricular Heart Block
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Postoperative AV Block
Patients diagnosed with postoperative AV block
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mortality
Tidsramme: 24 months after enrollment
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24 months after enrollment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Echocardiogram and Clinical Composite
Tidsramme: baseline and 24 months after enrollment
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baseline and 24 months after enrollment
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Roberto Costa, MD, PhD, University of Sao Paulo
- Ledende efterforsker: Roberto M Oliveira Jr, MD, University of Sao Paulo
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAPPesq nº 1248/09
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