Atrial FibrillationNCT06475547
Inflammation and Postoperative Atrial Fibrillation in Cardiac Surgery
An observational study of Atrial Fibrillation and Inflammation, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, marked by an irregular and rapid heart rate, and associated with increased morbidity, longer hospital stays, and higher costs. Its complex pathophysiology involves atrial remodeling, inflammation, and autonomic dysregulation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Inflammation
- What is being tested?
- Descriptive
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing cardiac surgery
Who may be able to join
- Age > 18
- Informed consent
Who cannot join
- Incompetent individuals
- General poor health condition at the time of inclusion
- Reoperation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital, Cardiac Surgery Department
Odense, 5000
About this study
Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, marked by an irregular and rapid heart rate, and associated with increased morbidity, longer hospital stays, and higher costs. Its complex pathophysiology involves atrial remodeling, inflammation, and autonomic dysregulation. Surgical trauma and cardiopulmonary bypass trigger an inflammatory response, releasing cytokines. Epicardial fat around the heart secretes pro-inflammatory cytokines, and its increased thickness is linked to higher inflammation and atrial fibrillation. This study uses RNA sequencing (RNA-seq) to profile gene expression in epicardial fat, identifying key genes involved in inflammation and metabolism. By comparing patients with and without POAF, RNA-seq reveals differentially expressed genes associated with postoperative atrial fibrillation.
Read the detailed description
Postoperative Atrial Fibrillation (POAF) after Cardiac Surgery Postoperative atrial fibrillation is a common complication following cardiac surgery, characterized by irregular and often rapid heart rate. It is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. The pathophysiology of POAF is complex and multifactorial, involving atrial structural and electrical remodeling, inflammation, and autonomic dysregulation.
Inflammation and Epicardial Fat Inflammation plays a significant role in the development of POAF. Surgical trauma and cardiopulmonary bypass trigger a systemic inflammatory response, releasing cytokines and other inflammatory mediators. Epicardial fat, the visceral fat depot around the heart, is an active endocrine organ secreting pro-inflammatory cytokines and adipokines. Increased epicardial fat thickness is associated with higher levels of inflammation and has been implicated in the pathogenesis of atrial fibrillation.
RNA isolation and sequencing RNA sequencing (RNA-seq) can be used to investigate gene expression in epicardial fat in several impactful ways. RNA-seq can profile gene expression to identify active genes in epicardial fat and their expression levels, revealing key genes involved in inflammation and metabolism. By comparing gene expression between groups, such as patients with and without POAF, RNA-seq can identify differentially expressed genes associated with atrial fibrillation.
RNA-seq analyses The RNA sequencing data files were aligned to the hg38 reference genome using the Spliced Transcripts Alignment to a Reference (STAR) aligner and read counts in genes were quantified. The resulting data matrix with unnormalized counts was loaded into RStudio together with patient metadata information (e.g., age, gender, BMI, smoking). Differential expression analyses were conducted with DESeq2 using adjustment for different variables, including type of tissue, age of patients, gender, and BMI.
Hypothesis The hypothesis that POAF may be influenced by pre-existing inflammation in epicardial fat, in addition to the inflammation caused by surgical trauma.
Objective:
To compare inflammatory gene expression in epicardial fat between patients who develop POAF and those who do not after elective cardiac surgery.
Study Design:
A prospective cohort study including patients undergoing first-time elective cardiac surgery.
Participants:
Inclusion criteria: Patients undergoing first-time elective cardiac surgery. Exclusion criteria: Patients with previous cardiac surgeries or emergency surgeries.
Groups:
POAF Group: Patients who develop POAF. Non-POAF Group: Patients who do not develop POAF.
Sample Collection:
Epicardial fat samples will be collected during the time of surgery.
RNA Isolation and Sequencing:
Homogenize adipose tissue in TRIzol using ceramic beads (Fastprep 24, MPBio). Purify RNA using EconoSpin columns (Epoch). Prepare RNA libraries with NEBNext Ultra II RNA Library Prep Kit for Illumina. Perform paired-end sequencing on the NovaSeq 6000 platform (Illumina).
Data Analysis:
Align RNA-seq data to the hg38 genome using STAR aligner. Quantify gene counts and perform differential expression analysis using DESeq2. Adjust for variables such as tissue type, age, gender, and BMI.
Outcome Measures:
Compare inflammatory gene expression profiles between POAF and Non-POAF groups at the time of surgery.
- Conditions
- Atrial Fibrillation, Inflammation
- Being tested
- Descriptive
- Medical subject headings
- Atrial Fibrillation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DescriptiveOther
This study is observational and does not involve any clinical intervention. The primary procedure involves the collection of epicardial fat tissue samples. The collected samples are then processed and analyzed to compare inflammatory gene expression between the two groups. The analysis includes RNA sequencing to identify differentially expressed genes associated with atrial fibrillation and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| POAF | Patients who develop postoperative atrial fibrillation. Receives: Other: Descriptive | |
| Non-POAF | Patients who do not develop postoperative atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of genes
The primary endpoint of this study is to identify differentially expressed (DE) genes using RNA sequencing (RNA-seq) data. Post-sequencing, we will utilize the default settings and statistical methods provided by DESeq2 to determining statistically significant differences in gene expression between the experimental conditions.
The gene signal is measured in normalized counts per kilobase or in Fragments Per Kilobase of transcript per Million mapped reads.
Measured: The sample is taken at the time of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lytfi Krasniqi, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475547
- Sponsor's protocol ID
- POAF130624
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available in anonymized form in accordance with GDPR upon reasonable request. Data will be shared with researchers whose proposed use has been approved, primarily for replication of our results.
Publications
Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25.
PubMed 23104886Love MI, Huber W, Anders S. Moderated estimation of fold change and dispersion for RNA-seq data with DESeq2. Genome Biol. 2014;15(12):550. doi: 10.1186/s13059-014-0550-8.
PubMed 25516281Wong CX, Ganesan AN, Selvanayagam JB. Epicardial fat and atrial fibrillation: current evidence, potential mechanisms, clinical implications, and future directions. Eur Heart J. 2017 May 1;38(17):1294-1302. doi: 10.1093/eurheartj/ehw045.
PubMed 26935271
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Postoperative Atrial Fibrillation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06475547
- Acronym / sponsor ID
- POAF130624
- Conditions
- Atrial Fibrillation, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 26 Jun 2024 (actual)
- 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.
Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, marked by an irregular and rapid heart rate, and associated with increased morbidity, longer hospital stays, and higher costs. Its complex pathophysiology involves atrial remodeling, inflammation, and autonomic dysregulation. Surgical trauma and cardiopulmonary bypass trigger an inflammatory response, releasing cytokines. Epicardial fat around the heart secretes pro-inflammatory cytokines, and its increased thickness is linked to higher inflammation and atrial fibrillation. This study uses RNA sequencing (RNA-seq) to profile gene expression in epicardial fat, identifying key genes involved in inflammation and metabolism. By comparing patients with and without POAF, RNA-seq reveals differentially expressed genes associated with postoperative atrial fibrillation.
Detailed description
Postoperative Atrial Fibrillation (POAF) after Cardiac Surgery Postoperative atrial fibrillation is a common complication following cardiac surgery, characterized by irregular and often rapid heart rate. It is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. The pathophysiology of POAF is complex and multifactorial, involving atrial structural and electrical remodeling, inflammation, and autonomic dysregulation.
Inflammation and Epicardial Fat Inflammation plays a significant role in the development of POAF. Surgical trauma and cardiopulmonary bypass trigger a systemic inflammatory response, releasing cytokines and other inflammatory mediators. Epicardial fat, the visceral fat depot around the heart, is an active endocrine organ secreting pro-inflammatory cytokines and adipokines. Increased epicardial fat thickness is associated with higher levels of inflammation and has been implicated in the pathogenesis of atrial fibrillation.
RNA isolation and sequencing RNA sequencing (RNA-seq) can be used to investigate gene expression in epicardial fat in several impactful ways. RNA-seq can profile gene expression to identify active genes in epicardial fat and their expression levels, revealing key genes involved in inflammation and metabolism. By comparing gene expression between groups, such as patients with and without POAF, RNA-seq can identify differentially expressed genes associated with atrial fibrillation.
RNA-seq analyses The RNA sequencing data files were aligned to the hg38 reference genome using the Spliced Transcripts Alignment to a Reference (STAR) aligner and read counts in genes were quantified. The resulting data matrix with unnormalized counts was loaded into RStudio together with patient metadata information (e.g., age, gender, BMI, smoking). Differential expression analyses were conducted with DESeq2 using adjustment for different variables, including type of tissue, age of patients, gender, and BMI.
Hypothesis The hypothesis that POAF may be influenced by pre-existing inflammation in epicardial fat, in addition to the inflammation caused by surgical trauma.
Objective:
To compare inflammatory gene expression in epicardial fat between patients who develop POAF and those who do not after elective cardiac surgery.
Study Design:
A prospective cohort study including patients undergoing first-time elective cardiac surgery.
Participants:
Inclusion criteria: Patients undergoing first-time elective cardiac surgery. Exclusion criteria: Patients with previous cardiac surgeries or emergency surgeries.
Groups:
POAF Group: Patients who develop POAF. Non-POAF Group: Patients who do not develop POAF.
Sample Collection:
Epicardial fat samples will be collected during the time of surgery.
RNA Isolation and Sequencing:
Homogenize adipose tissue in TRIzol using ceramic beads (Fastprep 24, MPBio). Purify RNA using EconoSpin columns (Epoch). Prepare RNA libraries with NEBNext Ultra II RNA Library Prep Kit for Illumina. Perform paired-end sequencing on the NovaSeq 6000 platform (Illumina).
Data Analysis:
Align RNA-seq data to the hg38 genome using STAR aligner. Quantify gene counts and perform differential expression analysis using DESeq2. Adjust for variables such as tissue type, age, gender, and BMI.
Outcome Measures:
Compare inflammatory gene expression profiles between POAF and Non-POAF groups at the time of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAF | – | Other: DescriptivePatients who develop postoperative atrial fibrillation. |
| Non-POAF | – | –Patients who do not develop postoperative atrial fibrillation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cardiac surgery
Key inclusion criteria (2 listed)
- Age > 18
- Informed consent
Key exclusion criteria (3 listed)
- Incompetent individuals
- General poor health condition at the time of inclusion
- Reoperation
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 |
|---|---|---|
| DescriptiveThis study is observational and does not involve any clinical intervention. The primary procedure involves the collection of epicardial fat tissue samples. The collected samples are then processed and analyzed to compare inflammatory gene expression between the two groups. The analysis includes RNA sequencing to identify differentially expressed genes associated with atrial fibrillation and inflammation. | Other | POAF |
Primary outcome
Differential expression of genes
Time frame: The sample is taken at the time of surgery.
The primary endpoint of this study is to identify differentially expressed (DE) genes using RNA sequencing (RNA-seq) data. Post-sequencing, we will utilize the default settings and statistical methods provided by DESeq2 to determining statistically significant differences in gene expression between the experimental conditions. The gene signal is measured in normalized counts per kilobase or in Fragments Per Kilobase of transcript per Million mapped reads.
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 15 Oct 2026.
- Background: PubMed 23104886Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25.
- Background: PubMed 25516281Love MI, Huber W, Anders S. Moderated estimation of fold change and dispersion for RNA-seq data with DESeq2. Genome Biol. 2014;15(12):550. doi: 10.1186/s13059-014-0550-8.
- Background: PubMed 26935271Wong CX, Ganesan AN, Selvanayagam JB. Epicardial fat and atrial fibrillation: current evidence, potential mechanisms, clinical implications, and future directions. Eur Heart J. 2017 May 1;38(17):1294-1302. doi: 10.1093/eurheartj/ehw045.
- Individual participant dataSharing planned: Yes. Data will be available in anonymized form in accordance with GDPR upon reasonable request. Data will be shared with researchers whose proposed use has been approved, primarily for replication of our results.
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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.
Lytfi Krasniqi, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Inflammation, run by Odense University Hospital at 1 site in Denmark.
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 2 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Differential expression of genes (time frame: The sample is taken at the time of surgery.). 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 NCT06475547, which also lists 3 linked publications.
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 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.