Quadruple UltrA-low-dose tReaTment for hypErTension - QUARTET

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001144404

Acronym

QUARTET

Enrollment

591

Registered

2016-08-23

Start date

2017-06-08

Completion date

2020-08-31

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The QUARTET Trial is a double-blind randomised controlled trial of low-dose quadruple combination therapy (LDQT) versus current guideline-based care. This study was funded by National Health and Medical Research Council. It aims to recruit 650 patients with high blood pressure (untreated or not controlled on one medication). Patients will be randomised to LDQT or irbesartan. The primary outcome is the difference between groups in office systolic blood pressure at 12 weeks.

Interventions

Low Dose Quadruple Combination Therapy (LDQT) – irbesartan 37.5mg, amlodipine 1.25mg, indapamide 0.625mg, bisoprolol 2.5mg. Oral capsule, once daily for 12 weeks, with option to continue study intervention drug up to 52 weeks for all participants

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• 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 device OR •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 device OR •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

Exclusion criteria

* 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

Outcome results