Key result
The QUADUAL trial is an ongoing randomized crossover study evaluating low-dose quadruple therapy versus standard-dose dual therapy for hypertension, with no results reported in this statistical analysis plan.
Why the study?
Hypertension guidelines support dual combination therapy for initial treatment, but whether low-dose quadruple therapy is better than standard-dose dual combination therapy is unknown.
Does low-dose quadruple antihypertensive therapy reduce mean 24-h systolic blood pressure more than standard-dose dual therapy in patients with mild to moderate hypertension?
RCT (n=90)
Double-blind
Stratified blocked randomization and individual random crossover
No
Does low-dose quadruple antihypertensive therapy reduce mean 24-h systolic blood pressure more than standard-dose dual therapy in patients with mild to moderate hypertension?
This statistical analysis plan outlines the methodology for the QUADUAL trial, which will evaluate whether a low-dose quadruple antihypertensive pill is superior to standard dual therapy for initial hypertension management.
Defines analysis for QUADUAL RCT of quadruple vs dual therapy; leaves open superiority for initial hypertension control.
BACKGROUND: Combined antihypertensive therapy has obvious advantages over single drug therapy. Hypertension guidelines fully affirm the efficacy of dual combination in initial antihypertensive therapy. Recent studies have also pointed out that the quadruple combination of very low-dose antihypertensive drugs is superior to single drugs. However, whether low-dose quadruple therapy is better than dual combination is unknown. METHODS/DESIGN: A randomized double-blind crossover clinical trial will be conducted to compare the efficacy and safety of low-dose quadruple antihypertensives (irbesartan 75 mg + metoprolol 23.75 mg + amlodipine 2.5 mg + indapamide 1.25 mg) with standard-dose dual antihypertensives (irbesartan 150 mg + amlodipine 5 mg) in the initial treatment of patients with mild to moderate hypertension (140-179/90-109 mmHg). Ninety patients are required and will be recruited and randomly assigned in a 1:1 ratio to two crossover groups. Two groups will receive a different combination therapy for 4 weeks, then switch to the other combination therapy for 4 weeks, with a 2-week wash-out. Antihypertensive effects and related adverse effects of the two antihypertensive combination treatments will be compared. The primary outcome, i.e., mean 24-h systolic blood pressure in ambulatory blood pressure monitoring, will be assessed via linear mixed-effects model. DISCUSSION: This statistical analysis plan will be confirmed prior to blind review and data lock before un-blinding and is sought to increase the validity of the QUADUAL trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05377203. Registered May 11, 2022, https://clinicaltrials.gov/study/NCT05377203 .
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Zhao et al. (2024) conducted an RCT in Mild to moderate hypertension (n=90). Low-dose quadruple antihypertensive therapy vs. Standard-dose dual antihypertensive therapy (irbesartan 150 mg + amlodipine 5 mg) was evaluated on Reduction in mean 24-h systolic blood pressure by ambulatory blood pressure monitoring after 4 weeks. The QUADUAL trial is an ongoing randomized crossover study evaluating low-dose quadruple therapy versus standard-dose dual therapy for hypertension, with no results reported in this statistical analysis plan.
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