Hypertension Control Based on Home Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine, Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>target morning home blood pressure (below 130 mmHg vs 130-139 mmHg) | Drug: Amlodipine, Losartan<br>* amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years<br>* Other names: other antihypertensive drugs (if required);|
| Active Comparator: 2<br>antihypertensive drug (amlodipine vs losartan) | Drug: Amlodipine, Losartan<br>* amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years<br>* Other names: other antihypertensive drugs (if required);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined cardiovascular events |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antihypertensive therapy, Home blood pressure, Systolic blood pressure, Morning blood pressure, Calcium antagonist, Angiotensin receptor antagonist