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

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ClinicalTrials.gov Identifier: NCT02377661
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
Ludwig Boltzmann Foundation for Cardiovascular Research
Information provided by (Responsible Party):
Thomas Weiss, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil, amlodipine, hydrochlorothiazide Phase 4

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  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lowering Blood Pressure in Primary Care in Vienna
Actual Study Start Date : March 2015
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Achievement of the target office blood pressure (< 140/90 mmHg) [ Time Frame: 6 months ]
    Proportion of patients achieving the target office blood pressure of 140/90 mmHg

  2. Achievement of the target systolic office blood pressure (< 140 mmHg) [ Time Frame: 6 months ]
    Proportion of patients achieving the target systolic office blood pressure of 140 mmHg

  3. Achievement of the target diastolic office blood pressure (< 90 mmHg) [ Time Frame: 6 months ]
    Proportion of patients achieving the target diastolic office blood pressure of 90 mmHg


Secondary Outcome Measures :
  1. Achievement of the target average 24h systolic ambulatory blood pressure (< 130 mmHg) [ Time Frame: 6 months ]
    Average 24h systolic ambulatory blood pressure reading below 130 mmHg

  2. Achievement of the target average 24h diastolic ambulatory blood pressure (< 80 mmHg) [ Time Frame: 6 months ]
    Average 24h diastolic ambulatory blood pressure reading below 80 mmHg

  3. Achievement of the target average daytime systolic ambulatory blood pressure (< 135 mmHg) [ Time Frame: 6 months ]
    Average daytime systolic ambulatory blood pressure reading below 135 mmHg

  4. Achievement of the target average nighttime systolic ambulatory blood pressure (< 120 mmHg) [ Time Frame: 6 months ]
    Average nighttime systolic ambulatory blood pressure reading below 120 mmHg

  5. Achievement of the target average daytime diastolic ambulatory blood pressure (< 85 mmHg) [ Time Frame: 6 months ]
    Average daytime diastolic ambulatory blood pressure reading below 85 mmHg

  6. Achievement of the target average nighttime diastolic ambulatory blood pressure (< 70 mmHg) [ Time Frame: 6 months ]
    Average nighttime diastolic ambulatory blood pressure reading below 70 mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377661


Locations
Austria
GP practices
Vienna, Austria
Sponsors and Collaborators
Wilhelminenspital Vienna
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Weiss, MD, PhD, MD, Wilhelminenspital Vienna
ClinicalTrials.gov Identifier: NCT02377661     History of Changes
Other Study ID Numbers: V1-19012014
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Olmesartan
Amlodipine
Hydrochlorothiazide
Olmesartan Medoxomil
Calcium Channel Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers