Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance.
BACKGROUND
Inhibitors of the renin angiotensin system are recommended as the first-line medications for diabetic hypertensive patients. However, there is less evidence supporting this recommendation especially among East Asians, a population with a unique distribution of cardiovascular disease compared to the Western population.


RESULTS
The NAGOYA HEART Study is a prospective randomized open-label blinded-endpoint study to compare an angiotensin II receptor blocker, valsartan, and a calcium channel blocker, amlodipine, regarding their efficacies on cardiovascular morbidity and mortality in Japanese hypertensive patients with glucose intolerance. Of 1168 eligible patients, we enrolled 1150 patients from October 2004 to January 2009. The participants will be followed for more than a median follow-up period of 3 years. The primary composite endpoint includes myocardial infarction, stroke, coronary revascularization, and admission due to congestive heart failure or sudden cardiac death. Any of these events are adjudicated by an independent committee under blinded information regarding the treatment arm. Secondary endpoints include all-cause mortality, changes in glucose tolerance status, kidney function, left ventricular structure measured by echocardiogram, and incident atrial fibrillation/flutter. The study was registered at ClinicalTrials.gov NCT00129233.


CONCLUSIONS
The NAGOYA HEART Study will provide us with a relevant insight for appropriate treatment of hypertension with glucose intolerance.
Matsushita
Kunihiro
K
Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya 466-8550, Japan.
Muramatsu
Takashi
T
Kondo
Takahisa
T
Maeda
Kengo
K
Shintani
Satoshi
S
Murohara
Toyoaki
T
D000328:Adult; 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*; D048909:Diabetes Complications / Q000188:drug therapy*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008875:Middle Aged; D011446:Prospective Studies; D013777:Tetrazoles / Q000627:therapeutic use*; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine