Hokkaido-Losartan/hydrochlorothiazide Investigation For End Point (H-LIFE study): Multi-center observational study on blood pressure control and cardio- and renoprotective effects of an ARB / diuretic combination in hypertensive patients in Hokkaido, Japan

UMIN ID: UMIN000001257

Registered date:22/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/06/01
• Target sample size: 1000
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1.Change in office blood-pressure 2.Change in BNP and NT-proBNP levels 3.Change in microalbuminuria, proteinuria and renal function
• Secondary Outcome: 1.Frequency of cardiovascular events (fatal and non-fatal myocardial infarction, unstable angina, angina that required hospitalization, coronary revascularization, stroke etc) 2.Frequency of renal events (end-stage renal disease [ESRD], deterioration in renal function, etc) 3.Mortality 4.Rates of adverse events 5.Exploratory subgroup analysis

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients with a history of hypersensitivity to ingredients of losartan/HCTZ 2)Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 3)Pregnant (positive on a urine pregnancy test prior to the study) or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 4)Patients with sever liver dysfunction 5)Patients with anuria or on dialysis 6)Patients with acute renal failure 7)Patients whose sodium and potassium levels in body fluids are clearly decreased

Related Information

• Primary Sponsor: Hokkaido Clinical Hypertension Research Group
• Source(s) of Monetary Support: Japan Heart Foundation