Atrial FibrillationPAINNCT05201989
Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Region Örebro County at 1 site in Sweden.
Trial summary
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one-fourth report severe symptoms. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2022to 10 Dec 2023
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 subjects who are planned for an AF ablation at Oerebro University Hospital, will be offered the chance to participate in the study. The subjects choice of whether they participate or not will not affect their planned ablation. The waiting list for AF ablation consists of subjects suffering from symptoms due to AF where ablation has been shown to reduce symptoms and improve quality of life. 100 controls without AF will be recruited through poster advertisements primarily at Oerebro University Hospital, Sweden. If needed, advertisements will be expanded to members of the general public who meet the inclusion criteria in the city of Oerebro, Sweden.
Who may be able to join
- On waiting list for AF ablation (only symptomatic subjects are offered ablation)
- Paroxysmal AF and persistent AF (AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion after ≥7 days)
- Written informed consent
Who cannot join
- Previous pulmonary vein isolation
- Cognitive or psychiatric condition
- Diabetes mellitus
- Ischemic heart disease
- Heart failure
- Asthma
Show all 10Show fewer
- Pregnancy
- Previous/current drug or alcohol abuse
- Previous neurological or concomitant musculoskeletal disorders
- Continuous analgesic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation Compared With Controls
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one-fourth report severe symptoms. It is unclear why patients' experience of AF-related symptoms varies so much. We have previously shown that patients with symptomatic AF exhibit lower pain tolerance than patients with asymptomatic AF, as well as impaired pain inhibitory control and facilitated summation of pain, indicating that pain sensitisation may be of importance in symptomatic AF. In patients with chronic pain conditions, several biomarkers and epigenetic markers associated with generation and /or maintenance of chronic pain have been identified. Previous research of biomarkers and epigenetic markers associated with pain is sparse in patients with AF.
The objective is to study levels of biomarkers and epigenetic markers in blood in patients with symptomatic paroxysmal AF (n=100), in relation to severity of AF symptoms, and compared to age- and sex-matched controls without AF (n=100). Blood will be obtained before and after AF ablation and levels of biomarkers, epigenetic markers and cardiac and inflammatory markers, analysed. Patients will complete an AF-specific symptom and a generic health-related quality of life questionnaire.
In the future, biomarkers and epigenetic markers associated with pain may be used as a tool for evaluation of patients with AF and have an impact on individualized management. Another possibility is a rationale for future studies of novel analgesics that neutralize biomarkers or antagonizes its receptors.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Symptoms, Quality of life, Pain
- Medical subject headings
- Atrial Fibrillation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation | Subjects with symptomatic paroxysmal atrial fibrillation scheduled for AF ablation at Örebro University hospital | |
| Control | Sex and age-matched subjects without AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers and epigenetic markers associated with pain
Blood tests will be obtained from subjects the day before, and the day after a planned AF ablation. A total of 30 ml of blood will be obtained at each occasion. The samples will be studied for the association of biomarkers and epigenetic markers to the severity of AF symptoms. Blood samples will be obtained from participants without AF (controls). Biomarkers and epigenetic markers will be compared between the control group and the group with symptomatic AF.
Measured: 3 days
Secondary outcomes (1)
Correlation of age, sex, AF duration, health-related quality of life to biomarkers and epigenetic markers.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start10 Jan 2022
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Anna Björkenheim, Region Örebro County
- Investigators
- Anna Björkenheim, MD, PhD, Principal investigator, Department of Cardiology, Örebro University Hospital and Örebro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201989
- Sponsor's protocol ID
- 276727
- Acronym
- PAIN
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan was shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark over e-mail in August 2021. The clinical study report and encoded data regarding patient characteristics and results from questionnaires and blood tests will be shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark, for statistical analysis. Data will be made available by an encrypted usb flash drive sent by post. There is no other plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation Compared With Controls
- ClinicalTrials.gov ID
- NCT05201989
- Acronym / sponsor ID
- PAIN / 276727
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Symptoms, Quality of life, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 21 Jan 2022 (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.
Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one-fourth report severe symptoms. It is unclear why patients' experience of AF-related symptoms varies so much. We have previously shown that patients with symptomatic AF exhibit lower pain tolerance than patients with asymptomatic AF, as well as impaired pain inhibitory control and facilitated summation of pain, indicating that pain sensitisation may be of importance in symptomatic AF. In patients with chronic pain conditions, several biomarkers and epigenetic markers associated with generation and /or maintenance of chronic pain have been identified. Previous research of biomarkers and epigenetic markers associated with pain is sparse in patients with AF.
The objective is to study levels of biomarkers and epigenetic markers in blood in patients with symptomatic paroxysmal AF (n=100), in relation to severity of AF symptoms, and compared to age- and sex-matched controls without AF (n=100). Blood will be obtained before and after AF ablation and levels of biomarkers, epigenetic markers and cardiac and inflammatory markers, analysed. Patients will complete an AF-specific symptom and a generic health-related quality of life questionnaire.
In the future, biomarkers and epigenetic markers associated with pain may be used as a tool for evaluation of patients with AF and have an impact on individualized management. Another possibility is a rationale for future studies of novel analgesics that neutralize biomarkers or antagonizes its receptors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation | – | –Subjects with symptomatic paroxysmal atrial fibrillation scheduled for AF ablation at Örebro University hospital |
| Control | – | –Sex and age-matched subjects without AF |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 subjects who are planned for an AF ablation at Oerebro University Hospital, will be offered the chance to participate in the study. The subjects choice of whether they participate or not will not affect their planned ablation. The waiting list for AF ablation consists of subjects suffering from symptoms due to AF where ablation has been shown to reduce symptoms and improve quality of life. 100 controls without AF will be recruited through poster advertisements primarily at Oerebro University Hospital, Sweden. If needed, advertisements will be expanded to members of the general public who meet the inclusion criteria in the city of Oerebro, Sweden.
Key inclusion criteria (3 listed)
- On waiting list for AF ablation (only symptomatic subjects are offered ablation)
- Paroxysmal AF and persistent AF (AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion after ≥7 days)
- Written informed consent
Key exclusion criteria (10 listed)
- Previous pulmonary vein isolation
- Cognitive or psychiatric condition
- Diabetes mellitus
- Ischemic heart disease
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers and epigenetic markers associated with pain
Time frame: 3 days
Blood tests will be obtained from subjects the day before, and the day after a planned AF ablation. A total of 30 ml of blood will be obtained at each occasion. The samples will be studied for the association of biomarkers and epigenetic markers to the severity of AF symptoms. Blood samples will be obtained from participants without AF (controls). Biomarkers and epigenetic markers will be compared between the control group and the group with symptomatic AF.
1 secondary outcome
Correlation of age, sex, AF duration, health-related quality of life to biomarkers and epigenetic markers.
Time frame: 1 day
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 16 Apr 2024.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan was shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark over e-mail in August 2021. The clinical study report and encoded data regarding patient characteristics and results from questionnaires and blood tests will be shared with Dennis Boye Larsen and Lars Arendt Nielsen in Aalborg, Denmark, for statistical analysis. Data will be made available by an encrypted usb flash drive sent by post. There is no other plan to make individual participant data available to other researchers.
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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.
Anna Björkenheim, MD, PhD principal investigator
Department of Cardiology, Örebro University Hospital and Örebro University
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, run by Region Örebro County at 1 site 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 3 inclusion and 10 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 16 Apr 2024. 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 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?
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?
Biomarkers and epigenetic markers associated with pain (time frame: 3 days). 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 16 Apr 2024.