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

NCT05201989 | Completed DMC

• 1 other identifier: 276727
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days

Secondary Outcomes (1)

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

  1 day

Study Arms (2)

Atrial fibrillation

Subjects with symptomatic paroxysmal atrial fibrillation scheduled for AF ablation at Örebro University hospital

Control

Sex and age-matched subjects without AF

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Aalborg University: collaborator

Study Sites (1)

Department of cardiology

Örebro, 70185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and whole blood

MeSH Terms

Conditions

Atrial Fibrillation; Pain

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Anna Björkenheim, MD, PhD

  Department of Cardiology, Örebro University Hospital and Örebro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: January 10, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The encoded individual participant data will be available for Dennis Boye Larsen and Lars Arendt Nielsen from 1st January 2022 to the end of September 2023.
• Access Criteria: Coded data will be available upon reasonable request.

Locations

SE (1)