Ultra-low-dose quadruple combination blood pressure lowering therapy in patients with hypertension: The QUARTET randomized controlled trial protocol.

Chow, CK; Atkins, ER; Billot, L; Chalmers, J; Hillis, GS; Hay, P; Neal, B; Nelson, M; Patel, A; Reid, CM; Schlaich, M; Usherwood, T; Webster, R; Rodgers, A

Ultra-low-dose quadruple combination blood pressure lowering therapy in patients with hypertension: The QUARTET randomized controlled trial protocol.

Chow, CK Atkins, ER Billot, L Chalmers, J Hillis, GS Hay, P Neal, B Nelson, M Patel, A Reid, CM Schlaich, M Usherwood, T Webster, R

Rodgers, A

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Publisher:: Elsevier
Publication Type:: Journal Article
Citation:: American Heart Journal, 2020, 231, pp. 56-67
Issue Date:: 2020-10-02

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Field	Value	Language
dc.contributor.author	Chow, CK
dc.contributor.author	Atkins, ER
dc.contributor.author	Billot, L
dc.contributor.author	Chalmers, J
dc.contributor.author	Hillis, GS
dc.contributor.author	Hay, P
dc.contributor.author	Neal, B
dc.contributor.author	Nelson, M
dc.contributor.author	Patel, A
dc.contributor.author	Reid, CM
dc.contributor.author	Schlaich, M
dc.contributor.author	Usherwood, T
dc.contributor.author	Webster, R https://orcid.org/0000-0002-7444-3037
dc.contributor.author	Rodgers, A
dc.date.accessioned	2020-11-14T20:53:07Z
dc.date.available	2020-09-27
dc.date.available	2020-11-14T20:53:07Z
dc.date.issued	2020-10-02
dc.identifier.citation	American Heart Journal, 2020, 231, pp. 56-67
dc.identifier.issn	0002-8703
dc.identifier.issn	1097-6744
dc.identifier.uri	http://hdl.handle.net/10453/144015
dc.description.abstract	High blood pressure is the leading cause of preventable morbidity and mortality globally. Many patients remain on single-drug treatment with poor control although guidelines recognize that most require combination therapy for blood pressure control. Our hypothesis is that a single-pill combination of four blood pressure- lowering agents each at a quarter dose may provide a simple, safe and effective blood pressure lowering solution which may also improve long term-adherence. The QUARTET (Quadruple UltrA-low-dose tReaTment for hypErTension) double-blind, active controlled, randomized clinical trial will examine whether ultra-low-dose quadruple combination therapy is more effective than guideline recommended standard care, in lowering blood pressure. QUARTET will enroll 650 participants with high blood pressure, either on no treatment or on monotherapy. Participants will be randomized 1:1 and allocated to intervention therapy of a single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg or to control therapy of a single identical appearing pill containing irbesartan 150 mg. In both arms step up therapy of open-label amlodipine 5mg will be provided if BP is >140/90 at 6weeks. The primary outcome is the difference between groups in the change from baseline in mean unattended automated office systolic blood pressure at 12weeks follow-up. The primary outcome and some secondary outcomes will be assessed at 12weeks, there is an optional 12months extension phase to assess longer term efficacy and tolerability. Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control. QUARTET will therefore provide evidence for the effectiveness and safety of a new paradigm in the management of high blood pressure.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Elsevier
dc.relation	http://purl.org/au-research/grants/nhmrc/1100377
dc.relation	http://purl.org/au-research/grants/nhmrc/1125044
dc.relation.ispartof	American Heart Journal
dc.relation.hasversion	Accepted Manuscript Version	en
dc.relation.isbasedon	10.1016/j.ahj.2020.09.017
dc.rights	info:eu-repo/semantics/embargoedAccess
dc.subject	1102 Cardiorespiratory Medicine and Haematology, 1117 Public Health and Health Services
dc.subject.classification	Cardiovascular System & Hematology
dc.title	Ultra-low-dose quadruple combination blood pressure lowering therapy in patients with hypertension: The QUARTET randomized controlled trial protocol.
dc.type	Journal Article
utslib.citation.volume	231
utslib.location.activity	United States
utslib.for	1102 Cardiorespiratory Medicine and Haematology
utslib.for	1117 Public Health and Health Services
pubs.organisational-group	/University of Technology Sydney/Faculty of Business
pubs.organisational-group	/University of Technology Sydney
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
utslib.copyright.embargo	2021-10-02T00:00:00+1000Z
dc.date.updated	2020-11-14T20:53:00Z
pubs.publication-status	Published
pubs.volume	231

Abstract:

High blood pressure is the leading cause of preventable morbidity and mortality globally. Many patients remain on single-drug treatment with poor control although guidelines recognize that most require combination therapy for blood pressure control. Our hypothesis is that a single-pill combination of four blood pressure- lowering agents each at a quarter dose may provide a simple, safe and effective blood pressure lowering solution which may also improve long term-adherence. The QUARTET (Quadruple UltrA-low-dose tReaTment for hypErTension) double-blind, active controlled, randomized clinical trial will examine whether ultra-low-dose quadruple combination therapy is more effective than guideline recommended standard care, in lowering blood pressure. QUARTET will enroll 650 participants with high blood pressure, either on no treatment or on monotherapy. Participants will be randomized 1:1 and allocated to intervention therapy of a single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg or to control therapy of a single identical appearing pill containing irbesartan 150 mg. In both arms step up therapy of open-label amlodipine 5mg will be provided if BP is >140/90 at 6weeks. The primary outcome is the difference between groups in the change from baseline in mean unattended automated office systolic blood pressure at 12weeks follow-up. The primary outcome and some secondary outcomes will be assessed at 12weeks, there is an optional 12months extension phase to assess longer term efficacy and tolerability. Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control. QUARTET will therefore provide evidence for the effectiveness and safety of a new paradigm in the management of high blood pressure.

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http://hdl.handle.net/10453/144015