ARENA - Project Atrial Fibrilation Rhine-Neckar Region

NCT ID: NCT02978248

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2777 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2021-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

1. ARENA Intervention:

This project will examine the effectiveness of population education and other measures to provide care for patients with atrial fibrillation.

In the end of the control phase (1 year recruitment of approximately 10,000 patients), there will be a wide publicity, informing about the disease.
2. ARENA Medication:

ARENA records the patient's complete medication at all survey times (up to two weeks after recruitment and follow up). This allows an accurate assessment of interactions between individual substances.

In addition, attempts are being made to determine drug concentrations of anticoagulants directly by the blood of the patient. Therefore, patients are provided with kits, which they can use to apply a drop of blood from your fingertip to a filter paper. The aim is to examine the patient's adherence and to analyze whether there are any complications.
3. ARENA Migration:

The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a Turkish migration background. ARENA migration aims to examine whether a targeted population education can improve the care of this patient group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willingness to participate
* Atiral fibrilation
* 18 years or older

Exclusion Criteria

* Not willing to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Borggrefe, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Walter E. Haefeli, Prof. Dr.

Role: STUDY_CHAIR

University Hospital Heidelberg

Ömer Sanatci, Dr. med.

Role: STUDY_CHAIR

Praxis Merz Sanatci

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39666256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39115608 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37977094 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARENA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EARLY-MYO-AF Registry
NCT04512222 RECRUITING