Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance
Kunihiro Matsushita, Takashi Muramatsu, Takahisa Kondo, Kengo Maeda, Satoshi Shintani, Toyoaki Murohara, NAGOYA HEART Study Group, Toyoaki Murohara, Takahisa Kondo, Satoshi Shintani, Kengo Maeda, Kunihiro Matsushita, Takashi Muramatsu, Masato Watarai, Nobuyuki Marui, Chiei Takanaka, Miyoshi Ohno, Toshihiro Obayashi, Taizo Kondo, Yasunobu Takada, Yoshio Iwama, Makoto Akahoshi, Masato Iida, Haruo Hirayama, Shizuoka Sone, Osamu Ohno, Shinji Kaneko, Satoshi Ichimiya, Tatsuaki Matsubara, Kimihiro Komori, Manabu Doyu, Hideaki Toyoshima, Yutaka Oiso, Makoto Hirai, Toyoaki Murohara, Takahisa Kondo, Satoshi Shintani, Kengo Maeda, Kunihiro Matsushita, Takashi Muramatsu, Kumi Sasaki, Emiko Watanabe, Yoko Inoue, Nobuo Shirahashi, Kunihiro Matsushita, Takashi Muramatsu, Takahisa Kondo, Kengo Maeda, Satoshi Shintani, Toyoaki Murohara, NAGOYA HEART Study Group, Toyoaki Murohara, Takahisa Kondo, Satoshi Shintani, Kengo Maeda, Kunihiro Matsushita, Takashi Muramatsu, Masato Watarai, Nobuyuki Marui, Chiei Takanaka, Miyoshi Ohno, Toshihiro Obayashi, Taizo Kondo, Yasunobu Takada, Yoshio Iwama, Makoto Akahoshi, Masato Iida, Haruo Hirayama, Shizuoka Sone, Osamu Ohno, Shinji Kaneko, Satoshi Ichimiya, Tatsuaki Matsubara, Kimihiro Komori, Manabu Doyu, Hideaki Toyoshima, Yutaka Oiso, Makoto Hirai, Toyoaki Murohara, Takahisa Kondo, Satoshi Shintani, Kengo Maeda, Kunihiro Matsushita, Takashi Muramatsu, Kumi Sasaki, Emiko Watanabe, Yoko Inoue, Nobuo Shirahashi
Abstract
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.
Methods and 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.
Conclusion: The NAGOYA HEART Study will provide us with a relevant insight for appropriate treatment of hypertension with glucose intolerance.
Copyright 2010 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Source: PubMed