Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-02-08 @ 12:11 AM
Study NCT ID:
NCT02377661
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lowering Blood Pressure in Primary Care in Vienna
Sponsor:
Wilhelminenspital Vienna
Organization:
Study Overview
Official Title:
Lowering Blood Pressure in Primary Care in Vienna
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Low BP 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: