Valsartan in Elderly Isolated Systolic Hypertension (VALISH) Study

This study has been completed.
Sponsor:
Collaborator:
Japan Cardiovascular Research Foundation
Information provided by:
VALISH study
ClinicalTrials.gov Identifier:
NCT00151229
First received: September 7, 2005
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.


Condition Intervention Phase
Elderly
Isolated Systolic Hypertension
Drug: Target blood pressure: <140mmHg
Drug: Target blood pressure: <150mmHg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Valsartan in Elderly Isolated Systolic Hypertension

Resource links provided by NLM:


Further study details as provided by VALISH study:

Primary Outcome Measures:
  • composite cardiovascular events as followed; [ Time Frame: report at any time and confirmation after study completion ] [ Designated as safety issue: Yes ]
  • sudden death
  • fatal or nonfatal stroke
  • fatal or nonfatal myocardial infarction
  • death due to heart failure
  • other cardiovascular death
  • unplanned hospitalization for cardiovascular disease
  • renal disorder

Secondary Outcome Measures:
  • Composite of hard endpoint; cadiovascular death, nonfatal stroke except transient ischemic attack, nonfatal myocardial infarction [ Time Frame: report at any time and confirmation after study completion ] [ Designated as safety issue: Yes ]
  • sudden death
  • stroke
  • myocardial infarction
  • heart failure
  • hospitalization
  • renal disorder

Estimated Enrollment: 3000
Study Start Date: October 2003
Estimated Study Completion Date: March 2008
Detailed Description:

Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients aged over 70 years and less than 85 years, regardless of sex.
  • Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
  • Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Exclusion Criteria:

  • Patients with secondary hypertension or malignant hypertension.
  • Patients with seated systolic blood pressure of over 200 mmHg.
  • Patients with seated diastolic blood pressure of over 90 mmHg.
  • Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
  • Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.
  • Patients with severe heart failure (NYHA functional classification III and IV).
  • Patients with severe aortic stenosis or valvular disease.
  • Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
  • Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
  • Patients with serious liver dysfunction.
  • Patients with a history of hypersensitivity to valsartan.
  • Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151229

Locations
Japan
VALISH Data Center
ING Corporation, 8-21, Shinjuku-ku, Tokyo, Japan, 162-0067
Sponsors and Collaborators
VALISH study
Japan Cardiovascular Research Foundation
Investigators
Principal Investigator: Toshio Ogihara, MD, PhD Department of Geriatric Medicine, Osaka University Graduate School of Medicine
Principal Investigator: Takao Saruta, MD, PhD Department of Internal Medicine, Keio University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00151229     History of Changes
Other Study ID Numbers: VAL-200310
Study First Received: September 7, 2005
Last Updated: June 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by VALISH study:
isolated systolic hypertension, valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014