Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02737215
Recruitment Status : Unknown
Verified March 2017 by Rodrigo Pinto Pedrosa, University of Pernambuco.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Rodrigo Pinto Pedrosa, University of Pernambuco

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Obstructive Sleep Apnea Coronary Artery Bypass Grafting Device: CPAP Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Active Comparator: CPAP group
patients will receive CPAP therapy for the first 7 days after extubation from CABG
Device: CPAP
patients will receive CPAP therapy with Auto-CPAP

No Intervention: Control Group
Patients will receive usal care

Primary Outcome Measures :
  1. atrial fibrillation [ Time Frame: first 7 days after CABG ]
    will be verified by holter monitoring

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • apnea-hypopnea index > 15 events/hour

Exclusion Criteria:

  • ejection fraction < 45%
  • chronic atrial fibrillation
  • periprocedural instability (haemodynamic, neurological)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02737215

Layout table for location contacts
Contact: RODRIGO P PEDROSA, PHD 55-81-31817179

Layout table for location information
Instituto de Medicina Integral Prof Fernando Figueira - Imip Recruiting
Recife, Pernambuco, Brazil, 50070-550
Pronto Socorro Cardiológico de Pernambuco - Procape Recruiting
Recife, PE, Brazil, 50.100-060
Contact: Rodrigo Pedrosa, PhD    55-81-31817179   
INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo Recruiting
Sao Paulo, SP, Brazil
Contact: Luciano F Drager, PhD   
Sponsors and Collaborators
Rodrigo Pinto Pedrosa

Layout table for additonal information
Responsible Party: Rodrigo Pinto Pedrosa, MD, PhD, University of Pernambuco Identifier: NCT02737215    
Other Study ID Numbers: PAFOS01
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases