Nocturnal hypertension is a risk factor of cardiovascular disease, especially in on-treatment patients. We developed an information and communications technology (ICT)-based home blood pressure (BP) monitoring device that automatically measures BP during sleep (Nocturnal HBPM). Angiotensin receptor blocker (ARB)/diuretic combination therapy (ADI) showed synergistic ability to decrease BP. ARB/calcium channel blocker combination therapy (ACC) showed an additive ability to decrease BP. To prospectively assess these therapies’ effects on nocturnal hypertension using Nocturnal HBPM, we conducted the NOCTURNE study, the first comparing the efficacy/safety of antihypertensive medication on nocturnal BP levels assessed by an ICT-based home BP device.Design and Method:
Japanese patients with uncontrolled nocturnal hypertension medicated by irbesartan 100 mg/day with nocturnal home BP > 120/70 mmHg (55.8% male, mean age 63 yrs) were randomly assigned to 8-week oral irbesartan 100 mg + trichlormethiazide 1 mg (ADI, n = 209) or irbesartan 100 mg + amlodipine 5 mg treatment (ACC, n = 207). Primary endpoint: a change in nocturnal systolic BP as measured by Nocturnal HBPM at the end of follow-up vs. the baseline during the run-in.Results:
The SBP/DBP mean ± SD of baseline nocturnal home BP and office BP were 128.5 ± 13.8/79.3 ± 8.4 mmHg and 145.9 ± 19.3/89.6 ± 12.6 mmHg, respectively. Randomization was successfully conducted without difference in age, sex, BMI, prevalence of diabetes, and serum NT-proBNP level. The study ends at the last follow-up on July 20, 2016.Conclusions:
Our findings will help identify appropriate antihypertensive treatment for hypertensive patients with disrupted circadian BP rhythm.