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
Sponsor:
Information provided by:
Jikei University School of Medicine
ClinicalTrials.gov Identifier:
NCT00133328
First received: August 22, 2005
Last updated: October 27, 2005
Last verified: January 2002

August 22, 2005
October 27, 2005
January 2002
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00133328 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
A Morbidity-Mortality and Remodeling Study With Valsartan
A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Ischemic Heart Disease
  • Congestive Heart Failure
Drug: valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
November 2005
Not Provided

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00133328
JHS2002
Not Provided
Not Provided
Jikei University School of Medicine
Not Provided
Study Chair: Seibu Mochizuki, MD., PhD The Jikei University School of Medicine
Jikei University School of Medicine
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP