NCT02737215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2016

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

3.6 years

First QC Date

April 10, 2016

Last Update Submit

December 1, 2021

Conditions

Atrial FibrillationObstructive Sleep ApneaCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

  • atrial fibrillation

    will be verified by holter monitoring

    first 7 days after CABG

Study Arms (2)

CPAP group

ACTIVE COMPARATOR

patients will receive CPAP therapy for the first 7 days after extubation from CABG

Device: CPAP

Control Group

NO INTERVENTION

Patients will receive usal care

Interventions

CPAPDEVICE

patients will receive CPAP therapy with Auto-CPAP

CPAP group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apnea-hypopnea index \> 15 events/hour

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pronto Socorro Cardiológico de Pernambuco - Procape

Recife, Pernambuco, 50.100-060, Brazil

Location

Instituto de Medicina Integral Prof Fernando Figueira - Imip

Recife, Pernambuco, 50070-550, Brazil

Location

INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Chalegre ST, Barros MM, Silva BPG, Furlan SF, Giampa SQC, Marques JN, Albuquerque ALT, Monteiro VS, Drager LF, Pedrosa RP. Impact of Continuous Positive Airway Pressure on Postoperative Atrial Fibrillation in Patients with Obstructive Sleep Apnea Undergoing Coronary Artery Bypass Graft Surgery: An Exploratory Randomized Multicenter Study. Am J Respir Crit Care Med. 2022 Aug 1;206(3):358-360. doi: 10.1164/rccm.202112-2669LE. No abstract available.

    PMID: 35549838DERIVED

MeSH Terms

Conditions

Atrial FibrillationSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 10, 2016

First Posted

April 13, 2016

Study Start

May 2, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(3)