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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06399666
Other study ID # Dnr 2023-02252-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 30, 2023
Est. completion date February 28, 2026

Study information

Verified date April 2024
Source Vrinnevi Hospital
Contact Jakob Hytting, MD
Phone +461010340807
Email jakob.hytting@liu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 205 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 205
Est. completion date February 28, 2026
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - persistent atrial fibrillation (ICD-10 I48.1), age over 18 years Exclusion Criteria: - autoimmune diseases, inflammatory diseases, acute or chronic liver dysfunction, ongoing infectious diseases, thyroid disorders, or any other conditions known to impact inflammatory activity (including medication use and hematological diseases)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling
Blood sampling

Locations

Country Name City State
Sweden Medical department Jönköping Småland
Sweden Cardiology Clinic Norrköping Östergötland

Sponsors (2)

Lead Sponsor Collaborator
Vrinnevi Hospital Ryhov Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence in atrial fibrillation During follow-up (post ECV, day 7 - 180)
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