Comparing morning and bedtime dosing of blood pressure medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of morning versus bedtime dosing of antihypertensive medications on blood pressure levels in patients with hypertension. It will utilize both ambulatory and home blood pressure monitoring to assess nighttime, daytime, and 24-hour blood pressure reductions. The study will involve a multicenter randomized design, focusing on the potential differences in blood pressure control and target organ protection based on the timing of medication administration. The trial will include patients aged 18-70 who have not previously been treated for hypertension.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged 18-70 years old;
2. Never treated for hypertension or stopped using antihypertensive drugs for at least 2 weeks;
3. In the two screenings,the clinical systolic BP should be in the range of 140-159 mmHg, the diastolic BP \< 100 mmHg;
4. The average 24-hour systolic BP ≥130mmHg, daytime systolic BP ≥ 135 mmHg, and nighttime systolic BP ≥ 120 mmHg;
5. The average of bilateral brachial-ankle pulse wave velocity ≥14m/s;
6. Be willing to participate in the trial, sign the informed consent form, and be able to visit doctors by himself or herself.

Exclusion Criteria:

1. Secondary hypertension;
2. Concomitant obstructive sleep apnea (STOP-BANG score ≥ 5), insomnia, Parkinson's syndrome, or nocturnal polyuria and other diseases that affect nighttime BP;
3. Need to work at night;
4. Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
5. Concomitant diseases that need taking medications influencing BP;
6. Coronary heart disease, myocardial infarction or stroke within recent 6 months;
7. Atrial fibrillation or frequent arrhythmia;
8. Abnormal liver function exemplified as an increased alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) over the double of the upper limit of normal range; abnormal renal function exemplified as a serum creatinine ≥176 µmol/L; and plasma potassium ≥5.5 mmol/L or ≤3.5mmol/L;
9. Pregnant or lactating women;
10. Contraindications of angiotensin II receptor blocker or calcium channel blocker;
11. Other concomitant diseases which are considered not suitable to participate in the trial, such as thyroid diseases, acute infectious diseases, chronic mental diseases, tumor, etc.

Where it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Li Yan, Professor
• Email: liyanshcn@163.com
• Phone: 021-64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.