Clinical trial NCT00129233: Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance
Official title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Type 2 Diabetes Mellitus
Keywords: cardiovascular disease
rennin-angiotensin system
calcium channel blocker
impaired glucose tolerance
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2005-08-11
Enrollment: 1150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension
* Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

Exclusion Criteria:

* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
* Taking calcium channel blocker for the purpose of angina pectoris
* Reduced ejection fraction (\< 40%)
* Second- or third-degree of atrioventricular block
* Severe hypertension (\> 200/110 mmHg) or secondary hypertension
* History of stroke in the recent 6 months
* Serum creatinine \> 2.5 mg/dl
* Estimated survival duration less than 3 years due to other conditions
* Pregnant woman or possibly pregnant woman

Primary outcomes:
measure: Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death
timeFrame: At least 3 years of mean follow up period
Secondary outcomes:
measure: total death
timeFrame: At least 3 years of mean follow up period
measure: cardiac function evaluated by ultrasonography
timeFrame: At least 3 years of mean follow up period
measure: incidence of atrial fibrillation/flutter
timeFrame: At least 3 years of mean follow up period
measure: control of blood glucose
timeFrame: At least 3 years of mean follow up period
measure: renal function
timeFrame: At least 3 years of mean follow up period
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Cardiology, Nagoya University Graduate School of Medicine
state: Aichi
Study officials:
affiliation: Department of Cardiology, Nagoya University Graduate School of Medicine
name: Toyoaki Murohara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, Hua T, Laragh J, McInnes GT, Mitchell L, Plat F, Schork A, Smith B, Zanchetti A; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004 Jun 19;363(9426):2022-31. doi: 10.1016/S0140-6736(04)16451-9.
citation: Yamashita K, Kondo T, Muramatsu T, Matsushita K, Nagahiro T, Maeda K, Shintani S, Murohara T. Effects of valsartan versus amlodipine in diabetic hypertensive patients with or without previous cardiovascular disease. Am J Cardiol. 2013 Dec 1;112(11):1750-6. doi: 10.1016/j.amjcard.2013.07.043. Epub 2013 Sep 13.
citation: Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, Ichimiya S, Ohno M, Sone T, Ikeda N, Watarai M, Murohara T; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study. Hypertension. 2012 Mar;59(3):580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226. Epub 2012 Jan 9.
citation: Matsushita K, Muramatsu T, Kondo T, Maeda K, Shintani S, Murohara T; NAGOYA HEART Study Group. Rationale and design of the NAGOYA HEART Study: comparison between valsartan and amlodipine regarding morbidity and mortality in patients with hypertension and glucose intolerance. J Cardiol. 2010 Jul;56(1):111-7. doi: 10.1016/j.jjcc.2010.03.004. Epub 2010 Apr 20.