An investigator initiated and conducted, multicentre, double blind randomised controlled trial to assess the effectiveness and tolerability of ultra-low-dose quadruple combination therapy (‘LDQT’) in participants with hypertension - QUARTET

The University of Sydney0 个研究点目标入组 591 人开始时间: 2016年8月23日最近更新: 2021年8月30日

研究概览

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•Adults (=18 years)
•Previous documentation of hypertension or high blood pressure (SBP 140-179mmHg and/or DBP 90-109 mmHg) from GP, pharmacist or health care professional
•And either meeting criteria A or B
•-Criteria A: In treatment naïve (i.e. never treated) or in patients currently not on treatment (not taken in last 4 weeks) either:
•A measure of Clinic SBP 140-179mmHg and/or DBP 90-109 mmHg
•documented by study staff in the last 12 weeks with a study automatic BP
•A recorded measure of daytime average SBP = 135 mmHg and/or DBP = 85
•mmHg on a 24 hour ambulatory BP monitoring device in the last 12 weeks
•-Criteria B: In patients currently taking one BP lowering drug ‘monotherapy’ (i.e. ACE-I, ARB, CCB, BB, aldosterone antagonist, alpha-blocker) either:
•A measure of Clinic SBP 130-179mmHg and/or DBP 85-109 mmHg
•documented by study staff in the last 12 weeks with a study automatic BP
•A recorded measure of daytime average SBP = 125 mmHg and/or DBP = 80
•mmHg on a 24 hour ambulatory BP monitoring device in the last 12 weeks

•* Contraindication to irbesartan, amlodipine, indapamide or bisoprolol
•* Evidence of secondary cause of hypertension e.g. renal artery stenosis; Significant renal impairment (eGRF <50), raised serum potassium (above lab normal limit)
•* Women who are pregnant, breast feeding and/ or of childbearing potential and not using effective contraception throughout the study (pharmacological or barrier methods)
•* Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments
•* Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
•* Participants responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy
•* Inability or unwillingness to provide written informed consent
•* Unable to complete study procedures including 24 hour ambulatory blood pressure
•* Definite indication for combination therapy

发起方