Japan Morning Surge-Total Organ Protection: JMS-TOP Study

UMIN ID: UMIN000001139

Registered date:29/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2005/04/01
• Target sample size: 450
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Evening administration of angiotensin II receptor blocker (Candesartan)
Morning administration of angiotensin II receptor blocker (Candesartan)

Outcome(s)

• Primary Outcome: Reduction of home morning blood pressure Improvements of hypertensive target organ damage measured as urinary albumin excretion ratio and brain-type natriuretic peptide
• Secondary Outcome: Changes in 24-hr blood pressure Changes in left ventricular hypertrophy(electrocardiogram and echocardiography), left ventricular diastolic function, carotid intima-media thickness, pulse wave velocity, augmentation index and baroreflex sensitivity

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Recent history (within 6 months) of ischemic heart disease, stroke (excluding transient ischemic attack), aortic dissection, and peripheral arterial disease. 2) History of admission due to heart failure 3) On hemodialysis 4) Chronic inflammatory disease (cancer, collagen disease) 5) Subjects who are difficult to get informed consent 6) Subjects who are unable to visit to hospitals/clinics 7) History of adverse effect with candesartan, and contraindications of candesartan 8) Atrial fibrillation 9) Bilateral renal arterial stenosis

Related Information

• Primary Sponsor: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
• Source(s) of Monetary Support: Japan Heart Foundation