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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Olmesartan medoxomil, amlodipine, 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.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • GP practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Treatment of hypertension according to current guidelines
Experimental: Experimental Care; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wilhelminenspital Vienna
• Collaborators: Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology; Ludwig Boltzmann Foundation for Cardiovascular Research
• Investigators: Principal Investigator: Thomas W Weiss, MD, PhD, 3rd Medical Department, Cardiology and Intensive Care Medicine Wilhelminenhospital, 1160 Vienna, Austria

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Olmesartan; Olmesartan Medoxomil; Hydrochlorothiazide
• Other Study ID Numbers: V1-19012014