Atrial FibrillationPAFOSNCT02737215
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
A study testing CPAP in people with Atrial Fibrillation and Obstructive Sleep Apnea, run by Rodrigo Pinto Pedrosa at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Obstructive Sleep Apnea, Coronary Artery Bypass Grafting
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesBrazil
- Study dates
- 2 May 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- apnea-hypopnea index > 15 events/hour
Who cannot join
- ejection fraction < 45%
- chronic atrial fibrillation
- periprocedural instability (haemodynamic, neurological)
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Pronto Socorro Cardiológico de Pernambuco - Procape
Recife, Pernambuco, 50.100-060
Instituto de Medicina Integral Prof Fernando Figueira - Imip
Recife, Pernambuco, 50070-550
INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo
About this study
Official title: Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
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.
- Being tested
- CPAP
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
patients will receive CPAP therapy with Auto-CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Active comparator | patients will receive CPAP therapy for the first 7 days after extubation from CABG Receives: Device: CPAP |
| Control Group | No intervention | Patients will receive usal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
will be verified by holter monitoring
Measured: first 7 days after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start2 May 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodrigo Pinto Pedrosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Pinto Pedrosa, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737215
- Sponsor's protocol ID
- PAFOS01
- Acronym
- PAFOS
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2016
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35549838
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
- ClinicalTrials.gov ID
- NCT02737215
- Acronym / sponsor ID
- PAFOS / PAFOS01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Rodrigo Pinto PedrosaUniversity, hospital or other
- Study start
- 2 May 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP group | Active comparator | Device: CPAPpatients will receive CPAP therapy for the first 7 days after extubation from CABG |
| Control Group | No intervention | –Patients will receive usal care |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- apnea-hypopnea index > 15 events/hour
Key exclusion criteria (3 listed)
- ejection fraction < 45%
- chronic atrial fibrillation
- periprocedural instability (haemodynamic, neurological)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPpatients will receive CPAP therapy with Auto-CPAP | Device | CPAP group |
Primary outcome
atrial fibrillation
Time frame: first 7 days after CABG
will be verified by holter monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 35549838Chalegre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Atrial Fibrillation and Obstructive Sleep Apnea, run by Rodrigo Pinto Pedrosa at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (time frame: first 7 days after CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.