Lowering Blood Pressure in Primary Care in Vienna (Low BP Vienna)

Wilhelminenspital Vienna

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT02377661

V1-19012014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 229 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Treatment of hypertension according to current guidelines

Experimental Care

Experimental group

Description:

Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Treatment:

Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide