Cardiovascular Diseases, Hypertension
Conditions
Brief summary
The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks. Further on, the study will evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of essential arterial hypertension (BP\>140/90 mm HG or BP\>130/80 mm Hg for diabetic patients) * at least an additional cardiovascular risk factor
Exclusion criteria
* hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market * pregnancy and lactation * diseases involving biliary obstruction * severe liver impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | Baseline to 3rd visit (4-10 months) | ESH is the European society of hypertension, and ESC is the European society of cardiology. |
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline to 3rd visit (4-10 months) | — |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline to 3rd visit (4-10 months) | — |
| Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event) | Baseline to 3rd visit (4-10 months) | A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. |
| Change From Baseline in Framingham CVD Risk Assessment Score | Baseline to 3rd visit (4-10 months) | 10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). |
| Change From Baseline in Framingham Stroke Risk Assessment Score | Baseline to 3rd visit (4-10 months) | The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | 3rd visit (4-10 months) | Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent. |
| Change in Heart Rate From Baseline to Study End | Baseline to 3rd visit (4-10 months) | — |
| Number of Patients With Adverse Events (AE) | 4-10 months | — |
| Number of Participants Not Completing Study | 3rd visit (4-10 months) | Number of participants discontinuing study early for given reason |
| Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC | 3rd visit (4-10 months) | ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients |
Countries
Slovenia
Participant flow
Pre-assignment details
Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.
Participants by arm
| Arm | Count |
|---|---|
| Micardis® 80mg; MicardisPlus® 80/12.5 mg | 211 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Continued with Tritace | 1 |
| Overall Study | Discontinued at target blood pressure | 2 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Micardis® 80mg; MicardisPlus® 80/12.5 mg |
|---|---|
| Additional antihypertensive treatment at baseline ACE inhibitors | 19 Percentage of participants |
| Additional antihypertensive treatment at baseline Beta Blockers | 39.3 Percentage of participants |
| Additional antihypertensive treatment at baseline Calcium Channel Blockers | 26.5 Percentage of participants |
| Additional antihypertensive treatment at baseline Diuretics | 15.2 Percentage of participants |
| Additional antihypertensive treatment at baseline Other | 7.6 Percentage of participants |
| Age Continuous | 64.4 years STANDARD_DEVIATION 10.4 |
| Gender Female | 90 Participants |
| Gender Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 211 |
| serious Total, serious adverse events | 2 / 211 |
Outcome results
Primary
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Diastolic Blood Pressure (DBP) | -10.1 mm Hg | Standard Deviation 10.1 |
Primary
Change From Baseline in Framingham CVD Risk Assessment Score
10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Framingham CVD Risk Assessment Score | -7.6 units on a scale | Standard Deviation 8.6 |
Primary
Change From Baseline in Framingham Stroke Risk Assessment Score
The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Framingham Stroke Risk Assessment Score | -3.6 units on a scale | Standard Deviation 8 |
Primary
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines
ESH is the European society of hypertension, and ESC is the European society of cardiology.
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | Average risk | 18 Participants moved into category |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | Low added risk | 7 Participants moved into category |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | Moderate added risk | -13 Participants moved into category |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Risk Assessment According to ESH/ESC Guidelines | Very high added risk | -12 Participants moved into category |
Primary
Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event) | -3.9 units on a scale | Standard Deviation 8.8 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change From Baseline in Systolic Blood Pressure (SBP) | -22.6 mm Hg | Standard Deviation 17.1 |
Secondary
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.
Time frame: 3rd visit (4-10 months)
Population: Patients with data at 3rd visit (4-10 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | ACE inhibitors | 19 Percentage of participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Diuretics | 11.2 Percentage of participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Calcium Channel Blockers | 32.2 Percentage of participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Beta Blockers | 36.1 Percentage of participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Other | 9.3 Percentage of participants |
Secondary
Change in Heart Rate From Baseline to Study End
Time frame: Baseline to 3rd visit (4-10 months)
Population: Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Change in Heart Rate From Baseline to Study End | -3.2 Beats per minute | Standard Deviation 9.2 |
Secondary
Number of Participants Not Completing Study
Number of participants discontinuing study early for given reason
Time frame: 3rd visit (4-10 months)
Population: Patients with data at 3rd visit (4-10 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Number of Participants Not Completing Study | Adverse Event | 2 Participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Number of Participants Not Completing Study | Lost to follow up | 4 Participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Number of Participants Not Completing Study | Discontinued at target BP | 2 Participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Number of Participants Not Completing Study | Continued with Tritace | 1 Participants |
Secondary
Number of Patients With Adverse Events (AE)
Time frame: 4-10 months
Population: Treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Number of Patients With Adverse Events (AE) | 4 Participants |
Secondary
Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC
ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients
Time frame: 3rd visit (4-10 months)
Population: Patients with data at 3rd visit (4-10 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC | Achieved target BP values | 32.8 Percentage of participants |
| Micardis® 80mg MicardisPlus® 80/12.5 mg | Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC | Not achieved target BP values | 67.2 Percentage of participants |