Clinical trial NCT00198562: Hypertension Control Based on Home Blood Pressure
Official title: Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Antihypertensive therapy
Home blood pressure
Systolic blood pressure
Morning blood pressure
Calcium antagonist
Angiotensin receptor antagonist
Lead sponsor: Ministry of Health, Labour and Welfare, Japan
Sponsor class: OTHER_GOV
Collaborators: name: Japan Cardiovascular Research Foundation
First posted: 2005-09-20
Enrollment: 2600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Combined cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: Total mortality
timeFrame: 5 years
measure: Cardiovascular mortality
timeFrame: 5 years
measure: Myocardial infarction and new-onset angina
timeFrame: 5 years
measure: Stroke and transient ischemic attack
timeFrame: 5 years
measure: Renal failure
timeFrame: 5 years
measure: Aortic and peripheral artery diseases
timeFrame: 5 years
measure: Left ventricular mass and function
timeFrame: 5 years
measure: Urinary albumin and renal function
timeFrame: 5 years
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
Study officials:
affiliation: Division of Hypertension and Nephrology, National Cardiovascular Center
name: Yuhei Kawano, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: