Clinical trial NCT02377661: Lowering Blood Pressure in Primary Care in Vienna
Official title: Lowering Blood Pressure in Primary Care in Vienna
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
Collaborators: name: Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
name: Ludwig Boltzmann Foundation for Cardiovascular Research
First posted: 2015-03-03
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of the target office blood pressure (< 140/90 mmHg)
timeFrame: 6 months
measure: Achievement of the target systolic office blood pressure (< 140 mmHg)
timeFrame: 6 months
measure: Achievement of the target diastolic office blood pressure (< 90 mmHg)
timeFrame: 6 months
Secondary outcomes:
measure: Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)
timeFrame: 6 months
measure: Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)
timeFrame: 6 months
measure: Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)
timeFrame: 6 months
measure: Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)
timeFrame: 6 months
measure: Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)
timeFrame: 6 months
measure: Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg)
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GP practices
Study officials:
affiliation: 3rd Medical Department, Cardiology and Intensive Care Medicine Wilhelminenhospital, 1160 Vienna, Austria
name: Thomas W Weiss, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rohla M, Tscharre M, Huber K, Weiss TW. Lowering blood pressure in primary care in Vienna (LOW-BP-VIENNA) : A cluster-randomized trial. Wien Klin Wochenschr. 2018 Dec;130(23-24):698-706. doi: 10.1007/s00508-018-1374-4. Epub 2018 Aug 15.