Arterial Hypertension
Conditions
Brief summary
The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension: opportunity for effective BP control with cOmbined antihypertensive therapy. The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical practice. Type of program: Multicenter, observational, non-controlled, open-label program. Investigators: Cardiologists and outpatient (primary care) physicians (general practitioners). Number of patients: 1,300 hypertensive patients.
Detailed description
It is multicenter, observational, non-controlled, open-label program. The baseline characteristics will be analyzed in all the patients who started the treatment (intention-to-treat \[ITT\] population). In case of significant differences between two treatment groups, the baseline characteristics will be provided for both of them. Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in the patients who completed the program without major deviations from protocol (per-protocol population \[PPP\]). The analysis of parameters with normal distribution will be performed using the Student's t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The percentage of patients with normalized BP, as well as the percentage of patients who responded to treatment (with 95% confidence intervals), will be calculated. Questionnaires: The score for each scale will be calculated as the sum of scores for questions constituting the scale. Assessment of the AEs will be carried out in all the patients who started the treatment (ITT population).
Interventions
DRUGamlodipine / indapamide / perindopril arginine FDC
CCB / diuretic / 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
* Age 18 to 79 years * Essential hypertension * Patient's consent to participate in the program * Doctor's decision to prescribe FDC of amlodipine / indapamide / perindopril arginine, according to the instruction for use, prior to the inclusion in the program.
Exclusion criteria
* Symptomatic, or secondary arterial hypertension * Office BP ≥ 180/110 mm Hg on treatment (at V0 visit) * History of myocardial infarction, unstable angina, or cerebrovascular accident within the past 1 year * CHF of class III-IV NYHA * Type I diabetes or decompensated type 2 diabetes * Diseases with severe organ dysfunction (hepatic failure, renal failure, etc.) * Contraindications to or known intolerance of dihydropyridine calcium channel blockers (including amlodipine) and/or indapamide and/or ACE inhibitors (including perindopril) and/or their fixed combination * Inability to understand the nature of the program and/or to follow the doctor's recommendations, including ones for the BP self-monitoring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline | Baseline, 3 months | Changes in the mean office systolic BP levels (in mm Hg) in the sitting position Blood pressure was measured in accordance with the guidelines of the European Society of Hypertension (ESH) using the auscultatory or oscillometric method and a semi-automated sphygmomanometer. Before taking measurements, the patient remained in a sitting position for 3-5 minutes. Blood pressure was determined on each arm, and the arm with the highest value was taken as the reference. Measurements were taken thrice in the sitting position of a patient, and the average of the second and third BP measurements on the reference arm with an interval of at least 1-2 minutes was recorded. |
| The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline. | Baseline, 3 months | Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline | Baseline, 3 months | The assessment of the target office BP levels (SBP \<140 mm Hg and DBP \<90 mm Hg) was performed in accordance with ESC Guidelines for the management of arterial hypertension (2013) |
| The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline | Baseline, 3 months | Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline | Baseline, 3 months | Change in the mean score of the of the physical component of the SF-36 survey Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Arterial Hypertension The patient is included in the program if prior to the study his/her doctor decided to adjust treatment, targeted at the BP control improvement, by prescription of a triple FDC of amlodipine / indapamide / perindopril arginine. The prescription of the triple FDC of amlodipine / indapamide / perindopril arginine during the program is made by the doctor's decision according to the instructions for medical use of this FDC.
Presumably, each doctor will include 4 patients in average. It is planned to include 1,300 patients.
amlodipine / indapamide / perindopril arginine FDC: CCB / diuretic / ACE inhibitor | 1,148 |
| Total | 1,148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Patient's decision (refusal to continue participation) | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 86 |
| Overall Study | Reason is not stated | 1 |
Baseline characteristics
| Characteristic | Patients With Arterial Hypertension |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 338 Participants |
| Age, Categorical Between 18 and 65 years | 810 Participants |
| Age, Continuous | 59.24 years STANDARD_DEVIATION 10.48 |
| Patients with arterial hypertension | 1148 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1148 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Russia | 1148 participants |
| Sex: Female, Male Female | 687 Participants |
| Sex: Female, Male Male | 451 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,148 |
| other Total, other adverse events | 9 / 1,148 |
| serious Total, serious adverse events | 3 / 1,148 |
Outcome results
Primary
The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline.
Changes in the mean office diastolic BP levels (in mm Hg) in the sitting position
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Arterial Hypertension | The Mean Diastolic BP Changes (mm Hg) at the Visit 4 vs Baseline. | 14.34 mm Hg | Standard Deviation 8.63 |
Primary
The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline
Changes in the mean office systolic BP levels (in mm Hg) in the sitting position Blood pressure was measured in accordance with the guidelines of the European Society of Hypertension (ESH) using the auscultatory or oscillometric method and a semi-automated sphygmomanometer. Before taking measurements, the patient remained in a sitting position for 3-5 minutes. Blood pressure was determined on each arm, and the arm with the highest value was taken as the reference. Measurements were taken thrice in the sitting position of a patient, and the average of the second and third BP measurements on the reference arm with an interval of at least 1-2 minutes was recorded.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Arterial Hypertension | The Mean Systolic BP Changes (mm Hg) at the Visit 4 vs. Baseline | 33.47 mm Hg | Standard Deviation 11.7 |
Secondary
Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline
The assessment of the target office BP levels (SBP \<140 mm Hg and DBP \<90 mm Hg) was performed in accordance with ESC Guidelines for the management of arterial hypertension (2013)
Time frame: Baseline, 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Arterial Hypertension | Percentage of Patients Who Achieved the Target Office BP Levels (SBP <140 mm Hg and DBP <90 mm Hg) at Visit 4 vs Baseline | 93.38 percentage of patients |
Secondary
The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline
Change in the mean score of the of the physical component of the SF-36 survey Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Arterial Hypertension | The Mean Standardized Score of the Mental Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline | 23.57 score on a scale | Standard Deviation 13.79 |
Secondary
The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline
Change in the mean score of the of the physical component of the The Short Form (36) Health Survey (SF-36) survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Arterial Hypertension | The Mean Standardized Score of the Physical Component of the Quality of Life Questionnaire The Short Form (36) Health Survey at Visit 4 vs Baseline | 13.64 score on a scale | Standard Deviation 18.06 |