TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium

Study Overview
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Brief Summary
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This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.

Official Title
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A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria.

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age above or equal to 18, no upper limit Patient has been treated and followed up for more than 6 months by the same general practitioner (GP) Hypertension treated for at least 3 months and not under control at the time of inclusion in the study [systolic blood pressure (SBP) above or equal to 140 mmHg and diastolic blood pressure (DBP) above or equal to 90 mmHg, or SBP above or equal to 130 mmHg and DBP above or equal to 80 mmHg if patient has chronic renal insufficiency or diabetes] Results available from at least two tests of albuminuria Antihypertensive treatment remained unchanged during the month prior data collection Decision by the GP to introduce telmisartan (either in combination with hydrochlorthiazide [HCTZ] or not) in the antihypertensive treatment (normal prescription) Written informed consent of the patient to collect his/her data Exclusion criteria: Blood pressure under control [SBP below 140 mmHg and DBP below 90 mmHg or SBP below 130 mmHg and DBP below 80 mmHg if patient has chronic renal insufficiency or diabetes] The patient refuse to allow his/her data to be collected Women of childbearing potential not using an effective contraception method, as well as women who are breastfeeding Patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (GFR) below 15 ml/min/1.73 m² Current or prior use of telmisartan within the last 12 months Change in the antihypertensive treatment during the month prior to collection of the data

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Telmisartan<br> | |
| Telmisartan + hydrochlorothiazide<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Controlled Blood Pressure | Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has: no chronic renal insufficiency or macroalbuminuria-dipsticks negative, albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine no diabetes or SBP < 130 mmHg and DBP < 80 mmHg if the patient has: chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine diabetes (type 1 or 2) | approximately 12 weeks (10 to 14 weeks) after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference in Systolic Blood Pressure | The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg | baseline and approximately 12 weeks | 
| Mean Difference in Diastolic Blood Pressure | The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg | baseline and approximately 12 weeks | 
| Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders) | The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg | approximately 12 weeks (10 to 14 weeks) after baseline | 
| Percentage of Patients Presenting an Adverse Event (AE) | Percentage of patients with any adverse events during the study period, related or not to investigational drug | baseline to the end of study period | 
| Percentage of Patients With Positive to Negative Shift in Albuminuria | Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks | Approximately 12 weeks (10 to 14 weeks) after baseline |