A Morbidity-Mortality and Remodeling Study With Valsartan

Hypertension Clinical Trial

Official title:

A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00133328
• Other study ID #: JHS2002
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 22, 2005
• Last updated: October 27, 2005
• Start date: January 2002
• Est. completion date: November 2005

Study information

• Verified date: January 2002
• Source: Jikei University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Coronary Artery Disease
• Heart Failure
• Hypertension
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
Japan	The Jikei University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Jikei University School of Medicine

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlöf B; JIKEI HEART Study Group. JIKEI HEART Study--a morbi-mortality and remodeling study with valsartan in Japanese patients with hypertension and cardiovascular disease. Cardiovasc Dr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke
Primary	new or recurrent transient ischemic attack
Primary	new or recurrent acute myocardial infarction
Primary	new occurrence or exacerbation of heart failure
Primary	new occurrence or exacerbation angina pectoris
Primary	dissecting aneurysm of the aorta
Primary	lower limb arterial obstruction
Primary	transition to dialysis
Primary	doubling of plasma creatinine (Cr) levels
Secondary	death from any cause
Secondary	left ventricular hypertrophy
Secondary	changes in ECG
Secondary	proteinuria
Secondary	B-type natriuretic peptide (BNP)
Secondary	heart failure symptoms
Secondary	heart failure syndrome (edema, rales on auscultation)
Secondary	blood pressure and heart rate