title: The Japan Morning Surge-1 (JMS-1) study: protocol description.
abstract: Morning blood pressure is reported to be more closely related to hypertensive organ damages such as left ventricular mass index, microalbuminuria and silent cerebral infarcts, than blood pressure at other times of the day. Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage. The Japan Morning Surge-1 (JMS-1) study includes hypertensive outpatients with elevated morning systolic blood pressure (>or=135 mmHg) as assessed by self-measured blood pressure monitoring at home. All enrolled patients are under stable antihypertensive medication status. Exclusion criteria are arrhythmia, chronic inflammatory disease, and taking alpha-blockers or beta-blockers. The target number of patients to be enrolled in the JMS-1 study is 600, and the aim is to evaluate differences in the markers of hypertensive target organ damage, such as brain natriuretic peptide and the urinary albumin excretion/creatinine ratio. All of the patients are randomized to an experimental group or a control group, with randomization to be carried out by telephone interviews with the patients' physicians. In the experimental group, patients begin taking additional antihypertensive medication just before going to bed. This consists of doxazosin 1 mg/day, which then is increased to 2 mg/day and 4 mg/day, with a beta-blocker added after a 1-month interval until the morning systolic blood pressure is controlled to less than 135 mmHg. Patients in the control group continue the treatment they are receiving at the enrollment for 6 months. Blood pressure levels, adverse effects, and hypertensive target organ damage before and after the study are evaluated. In the JMS-1 study, we will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alpha-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.
authors.affiliation: Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Japan.
authors.forename: Joji
authors.initials: J
authors.lastname: Ishikawa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hoshide
authors.forename: Seiichi
authors.initials: S
authors.lastname: Shibasaki
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Matsui
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Kabutoya
authors.forename: Kazuo
authors.initials: K
authors.lastname: Eguchi
authors.forename: Shizukiyo
authors.initials: S
authors.lastname: Ishikawa
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Pickering
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
mesh_terms: D000419:Albuminuria; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001795:Blood Pressure Determination; D002940:Circadian Rhythm; D002985:Clinical Protocols; D003401:Creatine / Q000652:urine; D017292:Doxazosin / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000378:metabolism; D007564:Japan; D020097:Natriuretic Peptide, Brain / Q000378:metabolism; D016032:Randomized Controlled Trials as Topic
chemical_list: D000959:Antihypertensive Agents; D020097:Natriuretic Peptide, Brain; D003401:Creatine; D017292:Doxazosin