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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,119
- 主要终点
- Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients
时间窗: At enrollment
次要结局
- CHA2DS2-VASc score in hypertensives without NVAF(At enrollment)
- Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF(At enrollment)
- Proportion of untreated patients among the study population diagnosed with NVAF(At enrollment)
- 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)
- Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF(At enrollment)
- CHA2DS2-VASc scores(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(At enrollment)
- Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement(At enrollment)
- CHADS2 scores(At enrollment)
- CHA2DS2-VASc score in hypertensives without AF(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)
- 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)