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NCT02978248 Clinical Trial

ARENA - Project Atrial Fibrilation Rhine-Neckar Region

Atrial Fibrillation Clinical Trial

— ARENA  

Official title:
Af Register RhEin NeckAr - Projekt Vorhofflimmern Rhein Neckar

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02978248
Other study ID # ARENA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date July 19, 2021

Study information
Verified date May 2022
Source Stiftung Institut fuer Herzinfarktforschung
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 2777
Est. completion date July 19, 2021
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Willingness to participate - Atiral fibrilation - 18 years or older Exclusion Criteria: - Not willing to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Prevented strokes in participants 10 years
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