Overview

This trial is active, not recruiting.

Conditions hypertension, ischemic heart disease, congestive heart failure
Treatment valsartan
Phase phase 4
Sponsor Jikei University School of Medicine
Start date January 2002
End date November 2005
Trial size 3000 participants
Trial identifier NCT00133328, JHS2002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 20 years up to 79 years old.

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

Additional Information

Official title A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Jikei University School of Medicine.