Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting

Study Overview
=================
Brief Summary
-----------------
One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.

Official Title
-----------------
Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary hypertension age>18 years Exclusion Criteria: Cholestatic disorders or severe hepatic/renal failure allergy to telmisartan or hydrochlorothiazide treatment-resistant hypokalemia or hypercalcemia pregnancy and lactation period

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 |
| --- | --- |
| Group 1<br> | Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)<br>* Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit |  | approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma potassium between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in fasting plasma glucose between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in glycated haemoglobin A1C between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in plasma high density lipoprotein between initial and (continued) |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in plasma low density lipoprotein between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in plasma cholesterol between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Change in plasma triglycerides between initial and final visit |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 
| Adverse events collection |  | approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Telmisartan, Hydrochlorothiazide, Potassium, Glucose metabolism, Lipid metabolism