Skip to main content
OpenTrials
Completed

NCT Number: NCT05201989

Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of cardiology

Örebro, 70185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous pulmonary vein isolation
  • Cognitive or psychiatric condition
  • Diabetes mellitus
  • Ischemic heart disease
  • Heart failure
  • Asthma
  • Pregnancy
  • Previous/current drug or alcohol abuse
  • Previous neurological or concomitant musculoskeletal disorders
  • Continuous analgesic medication

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation of age, sex, AF duration, health-related quality of life to biomarkers and epigenetic markers.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Aalborg University

Registry information

Official study title

Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation Compared With Controls

Acronym: PAIN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.