Lowering Blood Pressure in Primary Care in Vienna

Study Overview
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Brief Summary
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The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Detailed Description
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Rationale Hypertension is the single largest contributor to mortality worldwide, accounting for 13% of deaths globally. Approximately 30% of the adult population suffer from hypertension and of those diagnosed and treated, only 30-50% have adequately controlled blood pressure. At present, the importance of hypertension as fundamental risk factors is inadequately addressed among many patients and physicians. Design The aim of this prospective, randomised, open-label, multicentre clinical trial is to enhance blood pressure control in primary care by introducing a standardised and simplified titration regime with single pill combinations (SPC), comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide. The trial will randomise 42 family doctors or resident specialists for internal medicine (enrolling 840 patients with treated or untreated hypertension) to either experimental care or standard care for hypertension, latter according to the 2013 European Society of Cardiology Guidelines for the Management of Arterial Hypertension. Practitioners randomised to experimental care will up-titrate antihypertensive therapy with SPCs in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up (Figure 1). Study Outcomes The primary efficacy endpoint will be the proportion of patients achieving the target office blood pressure after 6 months of follow-up. The main secondary endpoint will be the improvement of 24h ambulatory blood pressure (ABPM) profile, measured at inclusion and after 6 months of follow-up. Safety assessments include the evaluation of treatment emergent adverse events, particularly hospitalisation, worsening of renal function, peripheral oedema and hypotension.

Official Title
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Lowering Blood Pressure in Primary Care in Vienna

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent office blood pressure ≥ 140/90 mmHg ACE inhibitor intolerance (experimental arm) Exclusion Criteria: Malignant disease with life expectancy < 6 months Women of childbearing potential (ICH definition) or breastfeeding Contraindications or allergies against olmesartan, amlodipine or hydrochlorothiazide (experimental arm) Chronic kidney disease grade IV or V (eGFR < 30 ml/min) Recent myocardial infarction or stroke within the preceding 3 months Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Treatment of hypertension according to current guidelines | |
| Experimental: Experimental Care<br>Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide. | Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide<br>* Up-titration of antihypertensive therapy with single pill combinations (comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide) in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of the target office blood pressure (< 140/90 mmHg) | Proportion of patients achieving the target office blood pressure of 140/90 mmHg | 6 months | 
| Achievement of the target systolic office blood pressure (< 140 mmHg) | Proportion of patients achieving the target systolic office blood pressure of 140 mmHg | 6 months | 
| Achievement of the target diastolic office blood pressure (< 90 mmHg) | Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg) | Average 24h systolic ambulatory blood pressure reading below 130 mmHg | 6 months | 
| Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg) | Average 24h diastolic ambulatory blood pressure reading below 80 mmHg | 6 months | 
| Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg) | Average daytime systolic ambulatory blood pressure reading below 135 mmHg | 6 months | 
| Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg) | Average nighttime systolic ambulatory blood pressure reading below 120 mmHg | 6 months | 
| Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg) | Average daytime diastolic ambulatory blood pressure reading below 85 mmHg | 6 months | 
| Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg) | Average nighttime diastolic ambulatory blood pressure reading below 70 mmHg | 6 months |