The effects of Olmesartan/amlodipine administered in the Morning or At Night on nocturnal blood pressure reduction in Chinese patients with mild-moderate essential hypertension (OMAN Trial): study protocol for a prospective, multicenter, randomized, open-label clinical trial {1}.

INTRODUCTION: Hypertension increases the risk of cardiovascular disease. Uncontrolled nocturnal blood pressure is prevalent in patients taking antihypertensive medication, with an incidence rate of 30-60%. Although chronotherapy with antihypertensive agents may provide a new direction for effective control of nocturnal blood pressure, the clinical evidence base remains controversial. This research is presently underway to compare the effects of morning and bedtime administration of antihypertensive medication on nocturnal reduction and circadian rhythm of blood pressure in patients with hypertension. METHODS AND ANALYSIS: This study is being performed as a randomized, multicenter, open-label, parallel-group, clinical trial in which 720 participants are to undergo 24-h ambulatory blood pressure measurement (ABPM) and office blood pressure measurement (OBPM) at baseline before being randomly assigned to a morning (6-10 am) or a bedtime (6-10 pm) administration group. Each participant receives one 20/5-mg tablet of olmesartan/amlodipine (OA) daily for 4 weeks and is then followed up at 4-week intervals for a total of 12 weeks. During follow-up, the OA dosage is adjusted according to the ABPM and OBPM results. Patients with uncontrolled hypertension at the first follow-up visit will receive an increase in OA dosage to 1.5 tablets/day. For patients with blood pressure that is still uncontrolled after a further 4 weeks, the dosage of OA can be increased to 2 tablets/day. The primary objective is the reduction in mean nocturnal systolic blood pressure between baseline and week 12. The secondary objectives are the reduction in ambulatory blood pressure at weeks 4 and 12 and the blood pressure control rate at weeks 4, 8, and 12. DISCUSSION: Antihypertensive chronotherapy remains controversial. A superiority test hypothesis design has been adopted for this trial, in which all participants will be taking the same antihypertensive medication. We anticipate that our findings will determine if nocturnal blood pressure control in Chinese patients with essential hypertension varies according to whether antihypertensive medication is taken in the morning or at bedtime. This study may provide scientific evidence for the application of chronotherapy in clinical practice. TRIAL REGISTRATION: ChiCTR2200059719. Registered on 10 May 2022 ( http://www.chictr.org.cn/edit.aspx?pid=169782&htm=4 ) {2a,2b}.

Buddhist Activities related to Sedentary behavior and Hypertension in Tibetan monks.

Previous studies suggest sedentary behavior (SB) is a risk factor for hypertension. However, buddhist activities related to SB in Tibetan monks is quite different from common SB. Meditation, chanting, and buddhist teaching are the main features during sitting. There is no study to examine the association between buddhist activities related to sitting and hypertension. There were 594 Tibetan monks included for analysis. Buddhist activities related to SB involve hours of meditation, chanting, and buddhist teaching for a typical weekday and weekend day. After controlling potential risk factors, compared with Tibetan monks who has the sedentary time < 8 h/d, those with 10 h/d ≤ sedentary time < 11 h/d was associated with about 80% decrease in the risk of hypertension (OR = 0.22;95% CI = 0.07-0.71), and about 90% decrease (OR = 0.11; 95% CI = 0.03-0.40) in those with sedentary time ≥ 11 h/d. In hypertension subgroup, buddhist activities related to SB is associated with a decrease in BP during linear regression analysis (standard ß = -0.355; P = 0.004 for SBP; standard ß = -0.345; P = 0.013 for DBP). We conclude that sitting might not simply represent the extremely low energy expenditure of the physical activity continuum. Psychosocial activities may play an important role in SB.