Arterial Hypertension, CHD - Coronary Heart Disease
Conditions
Brief summary
Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice. Type of the program: multicenter, observational, uncontrolled, open program. The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities.Each doctor includes four patients. It is planned to include not less than 1920 patients in total.
Detailed description
Multicenter observational open program. Assessment of the efficacy and tolerability of the fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and stable CAD in daily clinical practice (STYLE) Study objectives and purposes: Primary endpoints: * efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the BP * efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice regarding the angina Secondary endpoints: * impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice * adherence to bisoprolol/perindopril FDC therapy in patients with HT and stable CAD in everyday practice The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities. Each doctor includes four patients. It is planned to include not less than 1920 patients in total. Milestones of the program: FSI - November, 2018 LSLV- January, 2019 Database Lock - February, 2019 Statistic Report- May, 2019 Clinical Study Report- January, 2020
Interventions
DRUGbisoprolol/perindopril FDC
the first and only single-pill combination of beta-blocker and ACE inhibitor
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Stable CAD, defined as stable angina pectoris of class 1-3 by CCS (Canadian Cardiovascular Society) classification; * Previously or newly diagnosed essential hypertension * Age 18 to 79 years old; * Informed consent of the patient for participation in the program; * Decision of the doctor to prescribe bisoprolol/perindopril FDC before the inclusion in the program in accordance to the instruction for use.
Exclusion criteria
* Stable angina pectoris, class 4; * History of myocardial infarction or cerebrovascular event within the past 3 months; * Unstable angina within the past 6 months; * Chronic heart failure classes 3-4 (NYHA); * Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus; * Any serious decompensated concomitant diseases requiring the regular medical therapy; * Inability to understand the essence of the program and follow the recommendations; * Contraindications to beta-blockers or ACE inhibitors using; * Participation of the patient in other trials in the present time or within 30 days before the start of observational program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | 3 months | Changes in the mean office systolic BP levels (in mm Hg) in the sitting position |
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | 3 month | The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP \< 140 mm Hg and DBP \< 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC |
| Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | 3 month | Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC |
| Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | 3 months | Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | 3 month | Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC |
| Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | 3 month | Percentage of the patients with definite answer on question from questionnaire regarding adherence; (Compliance evaluation test - 6 questions tes; Answer No to all questions: good compliance; Answer Yes to 1-2 questions: minor compliance; Answer Yes to 3 or more questions: noncompliance) |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| the Patients With HT and Concomitant Stable CAD Observational study - 1 group - bisoprolol/perindopril FDC: single-pill combination of beta-blocker and ACE inhibitor | 1,892 |
| Total | 1,892 |
Baseline characteristics
| Characteristic | the Patients With HT and Concomitant Stable CAD | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 700 Participants | — |
| Age, Categorical Between 18 and 65 years | 1192 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 1909 participants | — |
| Sex: Female, Male Female | 1007 Participants | — |
| Sex: Female, Male Male | 874 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,909 |
| other Total, other adverse events | 2 / 1,909 |
| serious Total, serious adverse events | 7 / 1,909 |
Outcome results
Primary
Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position
Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position among the patints with HT and CAD recieving bis/perindopril FDC
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean of SBP Changes | Changes in the Mean Office Diastolic BP Levels (in mm Hg) in the Sitting Position | 15.9 mm Hg | Standard Deviation 9.5 |
Primary
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks
Average decrease of the number of angina attacks in patients with HT and stable CAD who recieved the bisoprolol/perindopril FDC
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean of SBP Changes | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: # of Angina Attacks | -3.2 number of angina attacks per week | Standard Deviation 8.2 |
Primary
Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels
The percentage of the patients achieved the target levels of clinical BP among included patients ( SBP \< 140 mm Hg and DBP \< 90 mm Hg) with HT and stable CAD recieving Bisoprolol/Perindopril FDC
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mean of SBP Changes | Efficacy of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice Regarding the BP: % of Patients Achieving Target Levels | 1640 Participants |
Primary
The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline
Changes in the mean office systolic BP levels (in mm Hg) in the sitting position
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean of SBP Changes | The Mean SBP Changes (mm Hg) at the Visit 3 vs. Baseline | 31.5 mm Hg | Standard Deviation 14.2 |
Secondary
Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice
Percentage of the patients with definite answer on question from questionnaire regarding adherence; (Compliance evaluation test - 6 questions tes; Answer No to all questions: good compliance; Answer Yes to 1-2 questions: minor compliance; Answer Yes to 3 or more questions: noncompliance)
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mean of SBP Changes | Good and Moderate Adherence to Bisoprolol/Perindopril FDC Therapy in Patients With HT and Stable CAD in Everyday Practice | 1827 Participants |
Secondary
Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS
Changes of the score in the visual analog scale (VAS) to assess the wellbeing; (minimum score 0 mm and maximum score 100 mm) among patients with HT and CAD recieving biso/perindopril FDC
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mean of SBP Changes | Impact on the Quality of Life of Bisoprolol/Perindopril FDC in Patients With HT and Stable CAD in Everyday Practice: VAS | 35.1 units on a scale - mm | Standard Deviation 18.5 |