Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
Overview
- Phase
- Phase 4
- Intervention
- Amlodipine, Losartan
- Conditions
- Hypertension
- Sponsor
- Ministry of Health, Labour and Welfare, Japan
- Enrollment
- 2600
- Locations
- 1
- Primary Endpoint
- Combined cardiovascular events
- Last Updated
- 18 years ago
Overview
Brief Summary
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs.
The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP <140 mmHg) or (2) strict control group (morning home BP <130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.
Detailed Description
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs. The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of hypertension
Exclusion Criteria
- •Severe hypertension (treated with 3 or more antihypertensive drugs)
- •Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
- •Serious medical conditions
- •Women who may become to be pregnant
Arms & Interventions
1
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
Intervention: Amlodipine, Losartan
2
antihypertensive drug (amlodipine vs losartan)
Intervention: Amlodipine, Losartan
Outcomes
Primary Outcomes
Combined cardiovascular events
Time Frame: 5 years
Secondary Outcomes
- Total mortality(5 years)
- Cardiovascular mortality(5 years)
- Myocardial infarction and new-onset angina(5 years)
- Stroke and transient ischemic attack(5 years)
- Renal failure(5 years)
- Aortic and peripheral artery diseases(5 years)
- Left ventricular mass and function(5 years)
- Urinary albumin and renal function(5 years)