APTH--a trial on ambulatory blood pressure monitoring and treatment of hypertension: objectives and protocol.
Study is to test the hypothesis that antihypertensive treatment based on ambulatory monitoring may be more beneficial than treatment guided by conventional sphygmomanometry. After a 2 month run-in period on placebo, eligible hypertensive patients (sitting diastolic pressure > 95 mm Hg on conventional measurement) will be randomized into 2 groups, one in which the target pressure is a sitting diastolic pressure from 80 through 89 mm Hg on conventional sphygmomanometry, and one in which a daytime (from 10 to 20 h) ambulatory diastolic pressure from 80 through 89 mm Hg should be achieved. For 6 months following randomization, treatment consisting of lisinopril 10-20 mg per day, associated with 12.5 mg hydrochlorothiazide and 5 mg amlodipine, as necessary, will be stepwise adjusted in order to reach the goal pressure. During this period of the trial the doctor making the therapeutic decisions at the Coordinating Office will be kept blinded with respect to the type of measurement guiding therapy. A final period of 4 months, during which treatment will be adjusted by the patient's personal physician according to the current recommendations, concludes the trial. The outcome measures include the blood pressure level on conventional and ambulatory measurement, the amount of drugs required to achieve the goal blood pressure, side-effects evaluated by a self-administered questionnaire and left ventricular mass as assessed by electrocardiography and echocardiography.
Department of Pathophysiology, Katholieke Universiteit Leuven, Belgium.
J
J
Staessen
A
A
Amery
D017311:Amlodipine / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001795:Blood Pressure Determination / Q000379:methods; D015924:Blood Pressure Monitors; D004151:Dipeptides / Q000627:therapeutic use; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy*; D017379:Hypertrophy, Left Ventricular / Q000175:diagnosis; D017706:Lisinopril; D012107:Research Design; D013997:Time Factors
D000959:Antihypertensive Agents; D004151:Dipeptides; D006852:Hydrochlorothiazide; D017311:Amlodipine; D017706:Lisinopril