Actively Recruiting
Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial
Led by Yan Li · Updated on 2025-01-06
300
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of taking antihypertensive medication in the morning versus at bedtime on blood pressure in adults with grade 1 day-night hypertension. This multicenter randomized controlled trial aims to understand whether the timing of medication affects nighttime, daytime, and 24-hour blood pressure reductions, as well as target organ protection. The study focuses on using a reliable wrist-type home blood pressure monitor to assess nighttime blood pressure, which has been linked more closely to cardiovascular risks than daytime or clinic measurements. Participants are randomly assigned to either take alisartan 120 mg once daily in the morning (6:00-10:00) or at bedtime (20:00-24:00). After 8 weeks, if blood pressure remains elevated, the alisartan dose is doubled to 240 mg. If blood pressure still remains high after 16 weeks, amlodipine besylate 2.5 mg is added once daily. This treatment plan lasts for a total of 24 weeks, with the same follow-up procedures for both groups. During the study, participants will have their blood pressure monitored using both ambulatory and home devices. Researchers will also assess arterial stiffness, heart structure changes, kidney function, and blood markers at various times. The main measurement is the reduction in nighttime systolic blood pressure after 24 weeks. Safety and effectiveness will be tracked through these evaluations, with study visits scheduled throughout the treatment period.
CONDITIONS
Brief Title
Morning Versus Bedtime Dosing of Antihypertensive Medication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18-70 years old
- Never treated for hypertension or stopped using antihypertensive drugs for at least 2 weeks
- Clinical systolic blood pressure between 140 and 159 mmHg, diastolic blood pressure less than 100 mmHg in two screenings
- Average 24-hour systolic blood pressure of at least 130 mmHg, daytime systolic blood pressure of at least 135 mmHg, and nighttime systolic blood pressure of at least 120 mmHg
- Average bilateral brachial-ankle pulse wave velocity of at least 14 m/s
- Willing to participate, able to sign informed consent, and able to visit doctors independently
You will not qualify if you...
- Secondary hypertension
- Obstructive sleep apnea (STOP-BANG score 5 or higher), insomnia, Parkinson's syndrome, nocturnal polyuria, or other diseases affecting nighttime blood pressure
- Night shift work
- Invalid ambulatory blood pressure monitoring (less than 70% valid readings, or fewer than 20 daytime or 7 nighttime readings)
- Use of medications affecting blood pressure for other diseases
- Coronary heart disease, myocardial infarction, or stroke within the last 6 months
- Atrial fibrillation or frequent arrhythmia
- Abnormal liver function (ALT, AST, or total bilirubin more than twice the upper normal limit), abnormal kidney function (serum creatinine above 176 µmol/L), or abnormal plasma potassium levels (below 3.5 or above 5.5 mmol/L)
- Pregnant or breastfeeding women
- Contraindications to angiotensin II receptor blockers or calcium channel blockers
- Other diseases deemed unsuitable for participation, such as thyroid disease, acute infections, chronic mental illness, or tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for blood pressure and health assessments
Duration - 24 weeks
Participants take antihypertensive medication once daily either in the morning or at bedtime, with possible dose adjustments based on blood pressure measurements during treatment.
Visits at baseline, 8 weeks, 16 weeks, and 24 weeks for medication adjustments and assessments
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Li Yan, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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