Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Effect of Telmisartan on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Conditions
-----------------
Hypertension, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with arterial hypertention<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. | Baseline to 3rd visit (4-10 months) | 
| 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). | Baseline to 3rd visit (4-10 months) | 
| 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). | Baseline to 3rd visit (4-10 months) | 
| 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. | Baseline to 3rd visit (4-10 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3rd visit (4-10 months) | 
| 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. | 3rd visit (4-10 months) | 
| 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 | Number of participants discontinuing study early for given reason | 3rd visit (4-10 months) |