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

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ClinicalTrials.gov Identifier: NCT02585076
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment
Hypertension Atrial Fibrillation Other: Standard of care

Study Type : Observational
Actual Enrollment : 1119 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Actual Study Start Date : November 4, 2015
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : May 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1
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
Other: Standard of care
As prescribed by treated physician




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

Secondary Outcome Measures :
  1. 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 ]
    HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly

  2. Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF [ Time Frame: At enrollment ]
  3. Proportion of untreated patients among the study population diagnosed with NVAF [ Time Frame: At enrollment ]
  4. Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF [ Time Frame: At enrollment ]
  5. CHADS2 scores [ Time Frame: At enrollment ]
    CHADS2 : Congestive heart failure, Hypertension, Age 75 years or older, Diabetes mellitus and prior Stroke or transient ischemic attack (doubled)

  6. CHA2DS2-VASc scores [ Time Frame: At enrollment ]
    CHA2DS2-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 category

  7. 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 ]
  8. CHA2DS2-VASc score in hypertensives without NVAF [ Time Frame: At enrollment ]
  9. 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 ]
    A 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 score

  10. CHA2DS2-VASc score in hypertensives without AF [ Time Frame: At enrollment ]
  11. 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 ]
    A 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 score

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


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585076


Locations
Greece
Many Locations, Greece
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02585076     History of Changes
Other Study ID Numbers: 18311
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

Keywords provided by Bayer:
Stroke prevention
Risk assessment

Additional relevant MeSH terms:
Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes