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

Sponsor

Rodrigo Pinto Pedrosa (Other)

Overall Status

Completed

CT.gov ID

NCT02737215

Collaborator

(none)

144

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

May 2, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

atrial fibrillation [first 7 days after CABG]
will be verified by holter monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

apnea-hypopnea index > 15 events/hour

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Medicina Integral Prof Fernando Figueira - Imip	Recife	Pernambuco	Brazil	50070-550
2	Pronto Socorro Cardiológico de Pernambuco - Procape	Recife	PE	Brazil	50.100-060
3	INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo	SP	Brazil

Sponsors and Collaborators

Rodrigo Pinto Pedrosa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rodrigo Pinto Pedrosa, MD, PhD, University of Pernambuco

ClinicalTrials.gov Identifier:

NCT02737215

Other Study ID Numbers:

PAFOS01

First Posted:

Apr 13, 2016

Last Update Posted:

Dec 9, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Atrial Fibrillation

Study Results

No Results Posted as of Dec 9, 2021