essential hypertension with type 2 diabetes mellitus
Conditions
Interventions
Patients are instructed to perform measurements of blood pressure every day within 1 hour of waking, after urination, after 1-2 min rest in a seated position, before taking antihypertensive drugs, and
130/80mmHg: step 1, routine dose of angiotensin receptor blocker (ARB)
step 2, routine doses of ARB and calcium channel blocker (CCB)
step 3, step1 + double dose of CCB
step 4, double doses of ARB and CCB
step 5, step 4 + routine dose of diuretic
step 6, step 5 + routine dose of beta-blocker
step 7, step 6 + routine dose of alpha-blocker
step 8, step 6 + double dose of alpha-blocker. The average of self-measured blood pressure for consecutive 7 days at baseline and at the end of each step is used for evaluation. Routine doses of antih
long acting nifedipine 40mg, amlodipine 5mg, benidipine 4mg (CCB)
trichrolothiazide 2mg, indapomide 1mg (diuretic)
bisoprolol 5mg, atenolol 50mg (beta-blocker)
and doxazosine 2mg (alpha-blocker). If clinic systolic and/or diastolic blood pressure exceeds the safety parameters of 180mmHg and/or 105mmHg, respectively, at any point, hypertensive medication will
Sponsors
Komono Kosei Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hypertensive patients with type 2 diabetes mellitus who are not being treated for hypertension
Exclusion criteria
Exclusion criteria: Exclusion criteria are: secondary hypertension; history of myocardial infarction, heart failure, angina pectoris, or stroke; uncontrolled diabetes mellitus (HbA1c >9.0%); a disorder that required treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, diuretics, or beta-blockers; renal artery stenosis; serum creatinine of 2.0mg/dl or more; pregnant women; or clinic systolic blood pressure >200mmHg and/or diastolic blood pressure >110mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the number of antihypertensive medications needed per patient to achieve the target home blood pressure goal. The step number of antihypertensive medication where the target blood pressure is achieved is considered as the number of antihypertensive medications needed for blood pressure control. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The average reduction of self-measured home blood pressure caused by a single mdication step in each patient calculated by the following equation: (baseline blood pressure) - (achieved blood pressure) / the step number where target blood pressure is achieved. (2) Self-measured blood pressure at home (3) Clinic blood pressure | — |
Countries
Japan
Outcome results
None listed