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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Standard of care Drug
    Intervention Desc: As prescribed by treated physician
    ARM 1: Kind: Experimental
    Label: Cohort 1
    Description: 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

Trial Design

  • Observation: Case-Only
  • Perspective: Cross-Sectional
  • Sampling: Probability Sample

Trial 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

Outcomes

Type Measure Time Frame Safety Issue
Primary Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients At enrollment No
Secondary Proportion of NVAF patients for whom the HAS-BLED score has been estimated by the physicians as part of the decision for antithrombotic treatment At enrollment No
Secondary Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF At enrollment No
Secondary Proportion of untreated patients among the study population diagnosed with NVAF At enrollment No
Secondary Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF At enrollment No
Secondary CHADS2 scores At enrollment No
Secondary CHA2DS2-VASc scores At enrollment No
Secondary Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systems At enrollment No
Secondary CHA2DS2-VASc score in hypertensives without NVAF At enrollment No
Secondary 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 At enrollment No
Secondary CHA2DS2-VASc score in hypertensives without AF At enrollment No
Secondary 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 At enrollment No
Secondary Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement At enrollment No

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