Valsartan Amlodipine Randomized Trial (VART): design, methods, and preliminary results.
Antihypertensive therapy has been well established to reduce hypertension related morbidity and mortality, but the optimal therapy for Japanese patients remains unknown. The Valsartan Amlodipine Randomized Trial (VART), a prospective randomized open-label trial, was designed to determine whether treatment with an angiotensin II type 1 receptor blocker (valsartan) or a calcium channel blocker (amlodipine) lowers cardiovascular disease events in essential hypertensives in Japan. Registration, randomization and data entry were performed over the Internet. The minimization method (to control for age, gender, blood pressure level and history) was used at random assignment to ensure that the background factors were equivalent between the groups at baseline. After the registration, patients were followed-up for cardiovascular events (primary endpoints), echocardiography, (123)I-metaiodobenzylguanidine (MIBG) imaging, laboratory tests and blood pressure for 3 years. Currently, 797 patients have been enrolled and assigned to two groups: a valsartan (n=399) and an amlodipine (n=398) group. At baseline, controlled factors (age, gender, blood pressure level, and left ventricular hypertrophy) and the proportions of patients with diabetes and hyperlipidemia were equally allocated. At 12 months, both drugs evenly and significantly lowered blood pressure to the target level (valsartan: 133/79 mmHg; amlodipine: 132/79 mmHg). In conclusion, by combining the data on cardiovascular events with the results of echocardiographic, radionuclide imaging, and blood/urine studies, the VART study will provide mechanistic insights into the clinical outcomes and treatment effects of the trial.
Nakayama
Keiko
K
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, Japan.
Kuwabara
Yoichi
Y
Daimon
Masao
M
Shindo
Satoshi
S
Fujita
Miwa
M
Narumi
Hiroya
H
Mizuma
Hiroshi
H
Komuro
Issei
I
D019797:3-Iodobenzylguanidine; D000368:Aged; D017311:Amlodipine / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000000981:diagnostic imaging / Q000188:drug therapy*; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D012107:Research Design; D012307:Risk Factors; D018401:Sample Size; D013777:Tetrazoles / Q000627:therapeutic use*; D014463:Ultrasonography; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D019275:Radiopharmaceuticals; D013777:Tetrazoles; D017311:Amlodipine; D019797:3-Iodobenzylguanidine; D000068756:Valsartan; D014633:Valine