Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan or Telmisartan and Hydrochlorthiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with arterial hypertension<br> | Drug: Telmisartan or Telmisartan and Hydrochlorthiazide<br>* Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | From baseline to visit 3 (6 months) | 
| 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) | From baseline to visit 3 (6 months) | 
| 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) | From baseline to visit 3 (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Visit 3 (6 months from baseline) | 
| 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 | Number of participants discontinuing study early for given reason | 3rd visit (6 months) | 
| Number of Patients With Adverse Events (AE) |  | 6 months |