Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP) Study: Prospective Randomized Open-label Blinded Endpoint (PROBE)

UMIN ID: C000000137

Registered date:09/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Untreated essential hypertensive patients
• Date of first enrollment: 2001/05/01
• Target sample size: 9000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Less intensive group (Home BP value 125/85-134/84 mmHg) and any angiotensin II receptor blockers as a first-line drug.
Less intensive group (Home BP value 125/85-134/84 mmHg) and any angiotensin converting enzyme inhibitors as a first-line drug.
Less intensive group (Home BP value 125/85-134/84 mmHg) and any calcium channel blockers as a first-line drug.
More intensive group (Home BP value under 125/85 mmHg) and any angiotensin II receptor blockers as a first-line drug.
More intensive group (Home BP value under 125/85 mmHg) and any angiotensin converting enzyme inhibitors as a first-line drug.
More intensive group (Home BP value under 125/85 mmHg) and any calcium channel blockers as a first-line drug.

Outcome(s)

• Primary Outcome: The composite of non-fatal stroke, non-fatal myocardial infarction, and cardiovascular death.
• Secondary Outcome: Cerebrovascular disease, coronary heart disease, heart failure, renal failure, peripheral vascular disease, cancer, pneumonia, occurrence of new diabetes and mortality by all causes.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Severe hypertension (either Home BP >= 180/120 mmHg or Clinic BP >= 220/125 mmHg), pure systolic hypertension (Home systolic BP >= 135 mmHg and Home diastolic BP =< 65 mmHg), pure diastolic hypertension (Home systolic BP =< 110 mmHg and Home diastolic BP >= 85 mmHg), or contra-indication to treatment with Ca-A, ACE-I, ARB.

Related Information

• Primary Sponsor: HOMED-BP Study Group
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation