HypertensionREFINE HTNCT02585076
A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension
An observational study of Hypertension and Atrial Fibrillation, run by Bayer at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Atrial Fibrillation
- How many people
- 1,119 participants
- Where
- 1 siteGreece
- Study dates
- 4 Nov 2015to 30 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Hypertension, Atrial Fibrillation
- Being tested
- Standard of care
- Keywords
- Stroke prevention, Risk assessment
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
As prescribed by treated physician
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients
Measured: At enrollment
Secondary outcomes (12)
Proportion of NVAF patients for whom the HAS-BLED score has been estimated by the physicians as part of the decision for antithrombotic treatment
HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly
Measured: At enrollment
Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF
Measured: At enrollment
Proportion of untreated patients among the study population diagnosed with NVAF
Measured: At enrollment
Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF
Measured: At enrollment
CHADS2 scores
CHADS2 : Congestive heart failure, Hypertension, Age 75 years or older, Diabetes mellitus and prior Stroke or transient ischemic attack (doubled)
Measured: At enrollment
CHA2DS2-VASc scores
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
Measured: At enrollment
Degree of agreement between the proportions of patients classified at intermediate and high stroke risk according to the two risk stratification systems
Measured: At enrollment
CHA2DS2-VASc score in hypertensives without NVAF
Measured: 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
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
Measured: At enrollment
CHA2DS2-VASc score in hypertensives without AF
Measured: 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
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
Measured: At enrollment
Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start4 Nov 2015
- Primary completion29 Feb 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585076
- Sponsor's protocol ID
- 18311
- Acronym
- REFINE HT
- Status last verified
- May 2017
- First submitted
- 20 Oct 2015
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02585076
- Acronym / sponsor ID
- REFINE HT / 18311
- Conditions
- Hypertension, Atrial Fibrillation
- Keywords
- Stroke prevention, Risk assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,119 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Standard of carePatients 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careAs prescribed by treated physician | Other | Cohort 1 |
Primary outcome
Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients
Time frame: At enrollment
12 secondary outcomes
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 oral anticoagulation therapy among the study population diagnosed with NVAF
Time frame: At enrollment
Proportion of untreated patients among the study population diagnosed with NVAF
Time frame: At enrollment
Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF
Time frame: At enrollment
CHADS2 scores
Time frame: At enrollment
CHA2DS2-VASc scores
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
CHA2DS2-VASc score in hypertensives without NVAF
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
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
Frequency of NVAF among the subpopulations of hypertensives adequately versus those inadequately controlled according to the physicians' medical judgement
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Atrial Fibrillation, run by Bayer at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of non-valvular atrial fibrillation (NAVF) among hypertensive outpatients (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.