Atrial FibrillationIERVNCT06399666
Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation
An observational study of Atrial Fibrillation and Inflammation, run by Vrinnevi Hospital at 2 sites in Sweden.
Trial summary
Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Inflammation, Genetic Predisposition to Disease
- What is being tested?
- Blood sampling
- How many people
- 182 participants
- Where
- 2 sitesSweden
- Study dates
- 30 Oct 2023to 28 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.
Who may be able to join
- Persistent atrial fibrillation (ICD-10 I48.1)
- Age over 18 years
Who cannot join
- Autoimmune disease
- Inflammatory diseases
- Acute or chronic liver dysfunction
- Ongoing infectious diseases
- Thyroid disorders
- Any other conditions known to impact inflammatory activity (including medication use and hematological diseases)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Medical department
Jönköping, Småland
Jakob Hytting, MD, jakob.hytting@liu.se
- Recruiting
Cardiology Clinic
Norrköping, Östergötland County
Jakob Hytting, MD, jakob.hytting@liu.se
About this study
Official title: Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial
Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.
This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \>18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.
An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.
- Being tested
- Blood sampling
- Medical subject headings
- Atrial Fibrillation, Inflammation, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Prospective cohort measuring the previously described biomarkers. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of AF
Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation
Measured: During follow-up (post ECV, day 7, 30, 90, and 180)
Secondary outcomes (1)
Fluctuations of biomarkers and gene expression during follow-up
Change in biomarker level or expression of gene expressions during follow-up.
Measured: During follow-up (post ECV, day 7, 30, 90, and 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start30 Oct 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrinnevi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ryhov County Hospital
- Responsible party
- Principal investigator, Jakob Hytting, Vrinnevi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399666
- Sponsor's protocol ID
- Dnr 2023-02252-01
- Acronym
- IERV
- Status last verified
- Sep 2024
- First submitted
- 30 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inflammatory Indexes and Gene Scores in Prediction of Atrial Fibrillation - IERV Trial
- ClinicalTrials.gov ID
- NCT06399666
- Acronym / sponsor ID
- IERV / Dnr 2023-02252-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Vrinnevi HospitalUniversity, hospital or other
- Collaborators
- Ryhov County Hospital
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 May 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.
Because of the high recurrence rates following electrical cardioversion and high morbidity in AF patients there is a need to explore prediction models for AF recurrence following ECV. Previous studies have primarily focused on high-sensitivity CRP (hsCRP), CRP, and IL-6, while other inflammatory indexes and gene scores might hold greater value.
This prospective cohort study is planning to include 182 patients with persistent atrial fibrillation, planned for electrical cardioversion, and \>18 years at two medium-sized hospitals in Sweden. Blood samples will be collected prior to electrical cardioversion and at 7-, 30-, 90-, and 180-days follow-up. Atrial fibrillation recurrence will be evaluated at follow-up or upon patient request and diagnosed with 12-lead ECG.
An interim analysis will be conducted after more than 80 patients have been included. If the results from univariate and/or multivariable logistic regression on inflammatory markers and genetic expression regarding atrial fibrillation recurrence are significant, the study will be concluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: Blood samplingProspective cohort measuring the previously described biomarkers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients aged 18 or older diagnosed with persistent atrial fibrillation (ICD-10 I48.1) scheduled for ECV. Inclusion took place from 2023-10-18 to 2025-06-01.
Key inclusion criteria (2 listed)
- Persistent atrial fibrillation (ICD-10 I48.1)
- Age over 18 years
Key exclusion criteria (6 listed)
- Autoimmune disease
- Inflammatory diseases
- Acute or chronic liver dysfunction
- Ongoing infectious diseases
- Thyroid disorders
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 |
|---|---|---|
| Blood samplingBlood sampling | Other | Prospective cohort |
Primary outcome
Recurrence of AF
Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)
Recurrence of atrial fibrillation or atrial flutter recorded on 12-lead ECG or through pacemaker interpretation
1 secondary outcome
Fluctuations of biomarkers and gene expression during follow-up
Time frame: During follow-up (post ECV, day 7, 30, 90, and 180)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
2 sites 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 Vrinnevi Hospital at 2 sites in Sweden.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob Hytting, MD (+46 + 707679724, jakob.hytting@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of AF (time frame: During follow-up (post ECV, day 7, 30, 90, and 180)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.