A Morbidity-Mortality and Remodeling Study With Valsartan

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2002 by Jikei University School of Medicine. Recruitment status was Active, not recruiting

First Received on August 22, 2005. Last Updated on October 27, 2005 History of Changes

Sponsor:	Jikei University School of Medicine
Information provided by:	Jikei University School of Medicine
ClinicalTrials.gov Identifier:	NCT00133328

Purpose

The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.

Condition	Intervention	Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure	Drug: valsartan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack Heart Diseases Heart Failure High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Jikei University School of Medicine:

Primary Outcome Measures:

stroke
new or recurrent transient ischemic attack
new or recurrent acute myocardial infarction
new occurrence or exacerbation of heart failure
new occurrence or exacerbation angina pectoris
dissecting aneurysm of the aorta
lower limb arterial obstruction
transition to dialysis
doubling of plasma creatinine (Cr) levels

Secondary Outcome Measures:

death from any cause
left ventricular hypertrophy
changes in ECG
proteinuria
B-type natriuretic peptide (BNP)
heart failure symptoms
heart failure syndrome (edema, rales on auscultation)
blood pressure and heart rate

Estimated Enrollment:	3000
Study Start Date:	January 2002
Estimated Study Completion Date:	November 2005

Detailed Description:

Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion Criteria:

Pregnancy
Severe renal damage
Severe liver damage
Acute myocardial infarction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133328

Locations

Japan
The Jikei University School of Medicine
Tokyo, Japan, 105-8461

Sponsors and Collaborators

Jikei University School of Medicine

Investigators

Study Chair:

Seibu Mochizuki, MD., PhD

The Jikei University School of Medicine

More Information

Publications:

Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlof B; The JIKEI HEART Study Group. JIKEI HEART Study--a morbi-mortality and remodeling study with valsartan in Japanese patients with hypertension and cardiovascular disease. Cardiovasc Drugs Ther. 2004 Jul;18(4):305-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mochizuki S, Dahlof B, Shimizu M, Ikewaki K, Yoshikawa M, Taniguchi I, Ohta M, Yamada T, Ogawa K, Kanae K, Kawai M, Seki S, Okazaki F, Taniguchi M, Yoshida S, Tajima N; Jikei Heart Study group. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28;369(9571):1431-9.

ClinicalTrials.gov Identifier:	NCT00133328 History of Changes
Other Study ID Numbers:	JHS2002
Study First Received:	August 22, 2005
Last Updated:	October 27, 2005
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Jikei University School of Medicine:

stroke
myocardial infarction
angina
renal damage

Additional relevant MeSH terms:

Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Heart Failure
Hypertension
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012