A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension (REFINE HT)

A National, Multicenter, Non-interventional, Crosssectional Study for the Determination of the pREvalence of Non-valvular Atrial FIbrillation Among patieNts Diagnosed With Hypertension Attending HEllenic Hypertension Centers

Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic events and mortality, AF has emerged as a global healthcare problem.

Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of a risk factor-based approach to stroke risk stratification for AF patients.

This study aims towards gaining real-world data on the prevalence of non-valvular atrial fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors influencing treatment decision-making will be assessed as well in patients diagnosed with the arrhythmia.

Finally, potential differences in the NVAF prevalence in adequately and inadequately controlled hypertensives will be documented.

Study Overview

• Status: Completed
• Conditions: Hypertension; Atrial Fibrillation
• Intervention / Treatment: Other: Standard of care

• Study Type: Observational
• Enrollment (Actual): 1119

Contacts and Locations

Study Locations

• Greece
  • Many Locations, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will be carried out by hypertension specialists practicing in the hospital-based outpatient healthcare sector, among the network of the European Society of Hypertension (ESH) Hypertension Excellence Centers

Description

Inclusion Criteria:

• Female and male outpatients aged 60 years and older
• Patients having being diagnosed with arterial hypertension
• For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice
• Patients with available medical records
• Written signed and dated informed consent

Exclusion Criteria

• Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder)
• Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Patients aged 60 years or older regardless of gender and race with a documented diagnosis of hypertension will be enrolled into this study after the decision for electrocardiographic screening for AF has been made by the investigator	Other: Standard of care; As prescribed by treated physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of NVAF patients for whom the HAS-BLED score has been estimated by the physicians as part of the decision for antithrombotic treatment	HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly	At enrollment
Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF		At enrollment
Proportion of untreated patients among the study population diagnosed with NVAF		At enrollment
Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF		At enrollment
CHADS2 scores	CHADS2 : Congestive heart failure, Hypertension, Age 75 years or older, Diabetes mellitus and prior Stroke or transient ischemic attack (doubled)	At enrollment
CHA2DS2-VASc scores	CHA2DS2-VASc: Congestive heart failure, Hypertension, Age 75 years or older (doubled), Diabetes mellitus, previous Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-74 years and Sex category	At enrollment
Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systems		At enrollment
CHA2DS2-VASc score in hypertensives without NVAF		At enrollment
Correlation of the CHA2DS2-VASc-assessed risk with the average annual stroke risk as calculated by the Framingham stroke risk scoring system in hypertensives without NVAF	A Poisson regression model or negative binomial model will be applied in order to examine the potential association of the Framingham stroke risk score with the CHA2DS2-VASc score	At enrollment
CHA2DS2-VASc score in hypertensives without AF		At enrollment
Correlation of the CHA2DS2-VASc-assessed risk with the average annual AF risk as calculated by the Framingham AF risk scoring system in hypertensives without AF	A Poisson regression model or negative binomial model will be applied in order to examine the potential association of the Framingham AF risk score with the CHA2DS2-VASc score	At enrollment
Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement		At enrollment

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2015
• Primary Completion (Actual): February 29, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Risk assessment; Stroke prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: 18311