Hypertension Control Based on Home Blood Pressure

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Amlodipine, Losartan

• Registration Number: NCT00198562
• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan

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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-22
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Amlodipine, Losartan	target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
2	Amlodipine, Losartan	antihypertensive drug (amlodipine vs losartan)

Primary Outcome Measures

Name	Time	Method
Combined cardiovascular events	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan