Comparing morning and bedtime dosing of blood pressure medication

Morning Versus Bedtime Dosing of Antihypertensive Medication in Grade 1 Day-night Hypertension: a Multicenter Randomized Controlled Trial (Dosing-Time Trial)

This study is testing whether taking blood pressure medication in the morning or at bedtime works better to lower blood pressure in people with high blood pressure who haven't been treated before.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Institute of Hypertension (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05089448 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with untreated hypertension or those who have stopped antihypertensive medications for at least two weeks.

Not a fit: Patients with secondary hypertension, obstructive sleep apnea, or other conditions affecting nighttime blood pressure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood pressure management strategies that enhance cardiovascular health.

How similar studies have performed: Previous studies have indicated the importance of nighttime blood pressure control, but this specific approach comparing dosing times in Chinese patients is novel.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li Yan, Professor

Conditions Hypertension; Blood Pressure; Drug Use