Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea

Atrial Fibrillation Clinical Trial

— PAFOS  

Official title:

Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737215
• Other study ID #: PAFOS01
• Status: Completed
• Phase: N/A
• Start date: May 2, 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2021
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background. Atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (CABG) surgery and usually associated with increased length of hospital stay and higher hospital costs. Among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with Holter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• apnea-hypopnea index > 15 events/hour

Exclusion Criteria:

• ejection fraction < 45%

• chronic atrial fibrillation

• periprocedural instability (haemodynamic, neurological)

Related Conditions & MeSH terms

• Apnea
• Atrial Fibrillation
• Coronary Artery Bypass Grafting
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
patients will receive CPAP therapy with Auto-CPAP

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Prof Fernando Figueira - Imip	Recife	Pernambuco
Brazil	Pronto Socorro Cardiológico de Pernambuco - Procape	Recife	PE
Brazil	INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Rodrigo Pinto Pedrosa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation	will be verified by holter monitoring	first 7 days after CABG