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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.
 
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

Tracking Information
First Submitted Date  ICMJE April 10, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date March 16, 2017
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2016)
atrial fibrillation [ Time Frame: first 7 days after CABG ]
will be verified by holter monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
Official Title  ICMJE Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Obstructive Sleep Apnea
  • Coronary Artery Bypass Grafting
Intervention  ICMJE Device: CPAP
patients will receive CPAP therapy with Auto-CPAP
Study Arms  ICMJE
  • Active Comparator: CPAP group
    patients will receive CPAP therapy for the first 7 days after extubation from CABG
    Intervention: Device: CPAP
  • No Intervention: Control Group
    Patients will receive usal care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2016)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • apnea-hypopnea index > 15 events/hour

Exclusion Criteria:

  • ejection fraction < 45%
  • chronic atrial fibrillation
  • periprocedural instability (haemodynamic, neurological)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737215
Other Study ID Numbers  ICMJE PAFOS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rodrigo Pinto Pedrosa, University of Pernambuco
Study Sponsor  ICMJE Rodrigo Pinto Pedrosa
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pernambuco
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP