NCT05201989Completed
Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation
Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation Compared With Controls
Source: ClinicalTrials.gov · Last updated 16 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 9 Jan 2022
- Start date
- 10 Jan 2022
- Primary completion date
- 10 Dec 2023
- Lead sponsor
- Region Örebro County
- Diseases
- Atrial fibrillation
- NCT number
- NCT05201989
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 10 Jan 2022 to the primary completion date, 10 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pulmonary vein isolation
- Previous/current drug or alcohol abuse
- Previous neurological or concomitant musculoskeletal disorders
- Continuous analgesic medication
Other illness
- Cognitive or psychiatric condition
- Diabetes mellitus
- Ischemic heart disease
- Heart failure
Other
- Asthma
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 20 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of cardiology Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.