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

NCT02585076 | Completed

• 1 other identifier: 18311
• Study Type: observational
• Target: 1,119
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Atrial Fibrillation

Keywords

Stroke prevention; Risk assessment

Outcome Measures

Primary Outcomes (1)

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

  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

  At enrollment

• Frequency of oral anticoagulation therapy among the study population diagnosed with NVAF

  At enrollment

• Proportion of untreated patients among the study population diagnosed with NVAF

  At enrollment

• Proportion of antiplatelet therapy treated patients among the study population diagnosed with NVAF

  At enrollment

• CHADS2 scores

  At enrollment

Study Arms (1)

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

Interventions

Standard of care OTHER

As prescribed by treated physician

Cohort 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Greece

Location

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: November 4, 2015
• Primary Completion: February 29, 2016
• Study Completion: May 30, 2016
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

GR (1)