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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02585076
• Date of registration: 20/10/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension REFINE HT
• Scientific 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
• Date of first enrolment: November 4, 2015
• Target sample size: 1119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02585076
• Study type: Observational
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Atrial Fibrillation

Intervention(s)

Other: Standard of care

Primary Outcome(s)

Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients [Time Frame: At enrollment]

Secondary Outcome(s)

CHA2DS2-VASc scores [Time Frame: At enrollment]

Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF [Time Frame: 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 [Time Frame: At enrollment]

Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement [Time Frame: At enrollment]

CHA2DS2-VASc score in hypertensives without AF [Time Frame: 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 [Time Frame: 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 [Time Frame: At enrollment]

Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF [Time Frame: At enrollment]

CHA2DS2-VASc score in hypertensives without NVAF [Time Frame: At enrollment]

Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systems [Time Frame: At enrollment]

CHADS2 scores [Time Frame: At enrollment]

Proportion of untreated patients among the study population diagnosed with NVAF [Time Frame: At enrollment]

Secondary ID(s)

18311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors