Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
NCT Number: NCT05089448
Previous studies have shown that elevated nighttime blood pressure (BP) was more closely associated with cardiovascular mortality and morbidity than daytime and clinic BPs. With increasingly advanced technology, not only 24-hour ambulatory but also home BP monitors can be used to evaluate nighttime BP. The validation study of the Omron HEM 9601T showed that the wrist-type home BP monitor could be a suitable and reliable tool for the diagnosis and management of nocturnal hypertension. However, up to now, there is no data on home nighttime BP in Chinese patients and it is unclear if different dosing time would reduce ambulatory and home nighttime BPs differently.
The investigators therefore designed a multicenter randomized clinical trial to compare between morning dosing and bedtime dosing of antihypertensive medications in the difference in nighttime, daytime and the 24-h BP reductions evaluated by both ambulatory and home BP monitoring, and in target organ protections.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drugs will be taken once daily at 6:00-10:00.
Time frame: 24 weeks
The difference between the morning and bedtime dosing groups in nighttime systolic BP reduction in mmHg measured by the ambulatory BP monitoring after the treatment for 24 weeks
Time frame: 24 weeks
The difference between the morning and bedtime dosing groups in the daytime and 24-hour systolic BPs reduction in mmHg measured by the ambulatory BP monitoring and home systolic BP reduction in mmHg after treatment for 24 weeks
Time frame: 12 and 24 weeks
The difference between the morning and bedtime dosing groups in reduction of brachial-ankle pulse wave velocity after treatment for 12 and 24 weeks
Time frame: 8 weeks and 24 weeks
The difference between the morning and bedtime dosing groups in change of Ambulatory night-to-day BP ratio change in percent; proportions of non-dippers in percent, and morning systolic blood pressure in mmHg after treatment for 8 and 24 weeks.
Time frame: 12 weeks and 24 weeks
The difference between the morning and bedtime dosing groups in change of microalbumine-to-creatinine ratio in random urine samples after treatment for 12 weeks and 24 weeks
Time frame: 12 weeks and 24 weeks
The difference between the morning and bedtime dosing groups in the change in prevalence (percentage) of left ventricular hypertrophy defined based on Cornell product and Sokolow-Lyon index in electrocardiogram after treatment for 12 weeks and 24 weeks
Time frame: 24 weeks
prevalence (percentage) of left ventricular hypertrophy defined based on left ventricular mass index assessed by echocardiography after treatment for 24 weeks
Time frame: 24 weeks
The difference between the morning and bedtime dosing groups in serum uric acid in umol/L after treatment for 24 weeks
Time frame: 24 weeks
The difference in daytime systolic and diastolic BPs between the ambulatory and home BP monitoring at baseline and after treatment for 24 weeks
Time frame: 24 weeks
The difference in nighttime systolic and diastolic BPs between the ambulatory and home BP monitoring at baseline and after treatment for 24 weeks
Contact information is provided by the study sponsor or research team.
Yan Li
Other
Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial (Dosing-Time Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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