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

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ClinicalTrials.gov 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
Sponsor:
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

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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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02737215


Contacts
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Contact: RODRIGO P PEDROSA, PHD 55-81-31817179 rppedrosa@terra.com.br

Locations
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Brazil
Instituto de Medicina Integral Prof Fernando Figueira - Imip Recruiting
Recife, Pernambuco, Brazil, 50070-550
Contact: RODRIGO PINTO PEDROSA RODRIGO PEDROSA    8196749991    rppedrosa@terra.com.br   
Pronto Socorro Cardiológico de Pernambuco - Procape Recruiting
Recife, PE, Brazil, 50.100-060
Contact: Rodrigo Pedrosa, PhD    55-81-31817179    rppedrosa@terra.com.br   
INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo Recruiting
Sao Paulo, SP, Brazil
Contact: Luciano F Drager, PhD       luciano.drager@incor.usp.br   
Sponsors and Collaborators
Rodrigo Pinto Pedrosa

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Responsible Party: Rodrigo Pinto Pedrosa, MD, PhD, University of Pernambuco
ClinicalTrials.gov 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:
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Apnea
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
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases