Lowering Blood Pressure in Primary Care in Vienna

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide

• Registration Number: NCT02377661
• Lead Sponsor: Wilhelminenspital Vienna

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.

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-03
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Care	Olmesartan medoxomil, amlodipine, hydrochlorothiazide	Treatment of hypertension using a standardised and simplified titration regime with single pill combinations, comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide.

Primary Outcome Measures

Name	Time	Method
Achievement of the target office blood pressure (< 140/90 mmHg)	6 months	Proportion of patients achieving the target office blood pressure of 140/90 mmHg
Achievement of the target systolic office blood pressure (< 140 mmHg)	6 months	Proportion of patients achieving the target systolic office blood pressure of 140 mmHg
Achievement of the target diastolic office blood pressure (< 90 mmHg)	6 months	Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg

Secondary Outcome Measures

Name	Time	Method
Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg)	6 months	Average 24h systolic ambulatory blood pressure reading below 130 mmHg
Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg)	6 months	Average daytime systolic ambulatory blood pressure reading below 135 mmHg
Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg)	6 months	Average nighttime systolic ambulatory blood pressure reading below 120 mmHg
Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg)	6 months	Average daytime diastolic ambulatory blood pressure reading below 85 mmHg
Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg)	6 months	Average nighttime diastolic ambulatory blood pressure reading below 70 mmHg
Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg)	6 months	Average 24h diastolic ambulatory blood pressure reading below 80 mmHg

Trial Locations

Locations (1)

GP practices; 🇦🇹 Vienna, Austria