ARENA - Project Atrial Fibrilation Rhine-Neckar Region | NCT02978248

Studies
ARENA - Project Atrial Fibrilation Rhine-Neckar Region

NCT02978248

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Status

Completed

Last Update Posted

Apr 12, 2023Actual

Enrollment

2,777Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jul 19, 2021Actual

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Nov 28, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

The study design includes three study arms:

ARENA Intervention: This project will examine the effectiveness of population education.
ARENA Medication: The aim is to examine the patient's adherence and to analyze whether there are any complications.
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

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

The study design includes three study arms:

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.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,777Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Prevented strokes in participants		10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willingness to participate
Atiral fibrilation
18 years or older

Exclusion Criteria:

Not willing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39666256	Derived	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.
39115608	Derived

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes