check_circleStudy Completed
Hypertension, Atrial fibrillation
Bayer Identifier:
18311
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A cross-sectional study for the determination of the prevalence of non-valvular atrial fibrillation among patients diagnosed with hypertension
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
60 - N/ATrial summary
Enrollment Goal
1119Trial Dates
November 2015 - May 2016Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Greece |
Primary Outcome
- Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatientsdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Proportion of NVAF patients for whom the HAS-BLED score has been estimated by the physicians as part of the decision for antithrombotic treatmentHAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantlydate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- Frequency of oral anticoagulation therapy among the study population diagnosed with NVAFdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- Proportion of untreated patients among the study population diagnosed with NVAFdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAFdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- CHADS2 scoresCHADS2 : Congestive heart failure, Hypertension, Age 75 years or older, Diabetes mellitus and prior Stroke or transient ischemic attack (doubled)date_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- CHA2DS2-VASc scoresCHA2DS2-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 categorydate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systemsdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- CHA2DS2-VASc score in hypertensives without NVAFdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- 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 NVAFA 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 scoredate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- CHA2DS2-VASc score in hypertensives without AFdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- 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 AFA 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 scoredate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
- Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians’ medical judgementdate_rangeTime Frame:At enrollmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A