NCT02978248

Brief Summary

ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation. The study design includes three study arms:

  1. 1.ARENA Intervention: This project will examine the effectiveness of population education.
  2. 2.ARENA Medication: The aim is to examine the patient's adherence and to analyze whether there are any complications.
  3. 3.ARENA Migration: ARENA migration aims to examine whether a targeted population education can improve the care of people with a Turkish migration background.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
Last Updated

April 12, 2023

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

November 23, 2016

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Prevented strokes in participants

    10 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with atrial fibrilation in the Rhein-Neckar Region in Germany, recruted by their general practitioner or during a hospital stay.

You may qualify if:

  • Willingness to participate
  • Atiral fibrilation
  • years or older

You may not qualify if:

  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (3)

  • Brockmuller C, Meid AD, Senges J, Hochadel M, Haefeli WE, Stoll F. Phenotypes of Patients with Direct Oral Anticoagulant (DOAC) Underdosing in Atrial Fibrillation: Results from the ARENA Registry. Clin Drug Investig. 2025 Jan;45(1):29-43. doi: 10.1007/s40261-024-01411-w. Epub 2024 Dec 12.

  • Zylla MM, Ozdemir B, Hochadel M, Zeymer U, Akin I, Grau A, Schneider S, Alonso A, Waldecker B, Suselbeck T, Schwacke H, Haass M, Zahn R, Borggrefe M, Senges J, Frey N, Thomas D. Community-based analysis of stroke prevention and effect of public interventions in atrial fibrillation: results from the ARENA project. Clin Res Cardiol. 2025 Jan;114(1):138-149. doi: 10.1007/s00392-024-02510-6. Epub 2024 Aug 8.

  • Sadlonova M, Salzmann S, Senges J, Celano CM, Huffman JC, Borggrefe M, Akin I, Thomas D, Schwarzbach CJ, Kleemann T, Schneider S, Hochadel M, Suselbeck T, Schwacke H, Alonso A, Haass M, Ladwig KH, Herrmann-Lingen C. Generalized anxiety is a predictor of impaired quality of life in patients with atrial fibrillation: Findings from the prospective observational ARENA study. J Psychosom Res. 2024 Jan;176:111542. doi: 10.1016/j.jpsychores.2023.111542. Epub 2023 Nov 8.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Borggrefe, Prof. Dr.

    Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR
  • Walter E. Haefeli, Prof. Dr.

    University Hospital Heidelberg

    STUDY CHAIR
  • Ömer Sanatci, Dr. med.

    Praxis Merz Sanatci

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 30, 2016

Study Start

August 1, 2016

Primary Completion

December 31, 2018

Study Completion

July 19, 2021

Last Updated

April 12, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations