Clinical trial NCT02585076: A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Atrial Fibrillation
Keywords: Stroke prevention
Risk assessment
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 1119
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients
timeFrame: At enrollment
Secondary outcomes:
measure: Proportion of NVAF patients for whom the HAS-BLED score has been estimated by the physicians as part of the decision for antithrombotic treatment
timeFrame: At enrollment
measure: Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF
timeFrame: At enrollment
measure: Proportion of untreated patients among the study population diagnosed with NVAF
timeFrame: At enrollment
measure: Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF
timeFrame: At enrollment
measure: CHADS2 scores
timeFrame: At enrollment
measure: CHA2DS2-VASc scores
timeFrame: At enrollment
measure: Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systems
timeFrame: At enrollment
measure: CHA2DS2-VASc score in hypertensives without NVAF
timeFrame: At enrollment
measure: 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
timeFrame: At enrollment
measure: CHA2DS2-VASc score in hypertensives without AF
timeFrame: At enrollment
measure: 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
timeFrame: At enrollment
measure: Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement
timeFrame: At enrollment
Other outcomes:
Locations:
city: Many Locations
country: Greece
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: