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Completed

NCT Number: NCT02585076

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

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.

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Key information

Conditions

Hypertension Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

As prescribed by treated physician

Primary outcomes

  1. Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients

    Time frame: At enrollment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: REFINE HT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2015
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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