Actively Recruiting
Morning Versus Bedtime Dosing of Antihypertensive Medication
Led by Yan Li · Updated on 2025-01-06
300
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 antihypertensive drugs for at least 2 weeks
- Clinical systolic blood pressure between 140-159 mmHg and diastolic blood pressure less than 100 mmHg in two screenings
- Average 24-hour systolic blood pressure 130 mmHg or higher, daytime systolic blood pressure 135 mmHg or higher, and nighttime systolic blood pressure 120 mmHg or higher
- Average bilateral brachial-ankle pulse wave velocity 14 m/s or higher
- Willing to participate, 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 conditions affecting nighttime blood pressure
- Need to work at night
- Invalid ambulatory blood pressure monitoring (less than 70% valid readings, fewer than 20 daytime readings or fewer than 7 nighttime readings)
- Diseases requiring medications that affect blood pressure
- Coronary heart disease, myocardial infarction, or stroke within the last 6 months
- Atrial fibrillation or frequent arrhythmia
- Abnormal liver function (ALT, AST, total bilirubin more than twice the upper normal limit), abnormal kidney function (serum creatinine 176 µmol/L or higher), or abnormal potassium levels (5.5 mmol/L or higher or 3.5 mmol/L or lower)
- Pregnant or breastfeeding women
- Contraindications to angiotensin II receptor blockers or calcium channel blockers
- Other diseases making participation unsuitable, such as thyroid diseases, acute infections, chronic mental diseases, or tumors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Li Yan, Professor
CONTACT
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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