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 risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.
Interventions
DRUGTelmisartan or Telmisartan and Hydrochlorthiazide
Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg
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 one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease
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, as prescribed in the SPC * pregnancy and lactation * diseases involving biliary obstruction * severe liver impairment * severe hypertension * malignant hypertension * secondary hypertension * patients age under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | From baseline to visit 3 (6 months) | ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available) |
| Change in Systolic Blood Pressure From Baseline to Study End | From baseline to visit 3 (6 months) | — |
| Change in Diastolic Blood Pressure From Baseline to Study End | From baseline to visit 3 (6 months) | — |
| Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | From baseline to visit 3 (6 months) | A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available) |
| Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | From baseline to visit 3 (6 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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) | Visit 3 (6 months from baseline) | 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 |
| Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | 6 Months | — |
| Change in Heart Rate From Baseline to Study End | From baseline to visit 3 (6 months) | — |
| Number of Participants Not Completing Study | 3rd visit (6 months) | Number of participants discontinuing study early for given reason |
| Number of Patients With Adverse Events (AE) | 6 months | — |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | 295 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg |
|---|---|
| Additional antihypertensive treatment at baseline ACE inhibitors | 53.1 Percentage of participants |
| Additional antihypertensive treatment at baseline Beta Blockers | 61.9 Percentage of participants |
| Additional antihypertensive treatment at baseline Calcium Channel Blockers | 35.1 Percentage of participants |
| Additional antihypertensive treatment at baseline Diuretics | 58.6 Percentage of participants |
| Additional antihypertensive treatment at baseline Other | 15.5 Percentage of participants |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 9.8 |
| Diastolic Blood Pressure (mean) | 97 mmHg STANDARD_DEVIATION 10.4 |
| Heart Rate | 79 beats/minute STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 172 Participants |
| Sex: Female, Male Male | 123 Participants |
| Systolic Blood Pressure (mean) | 171 mmHg STANDARD_DEVIATION 16.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 295 |
| serious Total, serious adverse events | 1 / 295 |
Outcome results
Primary
Change in Diastolic Blood Pressure From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Change in Diastolic Blood Pressure From Baseline to Study End | -17.8 mmHg | Standard Deviation 2.8 |
Primary
Change in Systolic Blood Pressure From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Change in Systolic Blood Pressure From Baseline to Study End | -39.2 mmHg | Standard Deviation 6.6 |
Primary
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End
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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | Positive | 58.3 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | Neutral | 10.2 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | Negative | 0.3 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End | Missing | 31.2 Percentage of participants |
Primary
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End
A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | Missing | 26.1 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | Positive | 64.8 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | Neutral | 8.8 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End | Negative | 0.3 Percentage of participants |
Primary
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End
ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | Positive | 65.1 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | Neutral | 12.9 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | Negative | 0.3 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End | Missing | 21.7 Percentage of participants |
Secondary
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Time frame: 6 Months
Population: Patients with data at 3rd visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | ACE inhibitors | 16.9 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Diuretics | 34.8 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Calcium Channel Blockers | 39.3 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Beta Blockers | 75.1 Percentage of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) | Other | 20.9 Percentage of participants |
Secondary
Change in Heart Rate From Baseline to Study End
Time frame: From baseline to visit 3 (6 months)
Population: Patients with data both at baseline and on 3rd visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Change in Heart Rate From Baseline to Study End | -7.6 beats / minute | Standard Deviation 3.9 |
Secondary
Number of Participants Not Completing Study
Number of participants discontinuing study early for given reason
Time frame: 3rd visit (6 months)
Population: Patients with data at 3rd visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Number of Participants Not Completing Study | Adverse Event | 3 Number of participants |
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Number of Participants Not Completing Study | Lost to follow up | 1 Number of participants |
Secondary
Number of Patients With Adverse Events (AE)
Time frame: 6 months
Population: Treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Number of Patients With Adverse Events (AE) | 4 Number of participants |
Secondary
Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (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: Visit 3 (6 months from baseline)
Population: Patients with data at 3rd visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg | Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC) | 57.3 Percentage of participants |