- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151229
Valsartan in Elderly Isolated Systolic Hypertension Study (VALISH)
June 3, 2015 updated by: Hiromi Rakugi, MD, PhD, VALISH study
Valsartan in Elderly Isolated Systolic Hypertension
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3079
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
ING Corporation, 8-21, Shinjuku-ku, Tokyo, Japan, 162-0067
- VALISH Data Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: strict control
systolic blood pressure control: less than 140 mm Hg
|
|
Active Comparator: moderate control
systolic blood pressure control: 140 mm Hg to 149 mm Hg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
composite cardiovascular events
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
sudden death, fatal or nonfatal stroke, fatal or nonfatal myocardial infarction, death because of heart failure, other cardiovascular death, unplanned hospitalization for cardiovascular disease, and renal dysfunction (doubling of serum creatinine to a level 2.0 mg per 100 mL or introduction of dialysis).
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sudden death
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
stroke
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
myocardial infarction
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
heart failure
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
hospitalization
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
renal disorder
Time Frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
participants will be followed for the duration of the study, an expected median follow-up 3.07 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ogihara T, Saruta T, Matsuoka H, Shimamoto K, Fujita T, Shimada K, Imai Y, Nishigaki M. valsartan in elderly isolated systolic hypertension (VALISH) study: rationale and design. Hypertens Res. 2004 Sep;27(9):657-61. doi: 10.1291/hypres.27.657.
- Ogihara T, Saruta T, Rakugi H, Matsuoka H, Shimamoto K, Shimada K, Imai Y, Kikuchi K, Ito S, Eto T, Kimura G, Imaizumi T, Takishita S, Ueshima H; Valsartan in Elderly Isolated Systolic Hypertension Study Group. Target blood pressure for treatment of isolated systolic hypertension in the elderly: valsartan in elderly isolated systolic hypertension study. Hypertension. 2010 Aug;56(2):196-202. doi: 10.1161/HYPERTENSIONAHA.109.146035. Epub 2010 Jun 7.
- Yano Y, Rakugi H, Bakris GL, Lloyd-Jones DM, Oparil S, Saruta T, Shimada K, Matsuoka H, Imai Y, Ogihara T. On-Treatment Blood Pressure and Cardiovascular Outcomes in Older Adults With Isolated Systolic Hypertension. Hypertension. 2017 Feb;69(2):220-227. doi: 10.1161/HYPERTENSIONAHA.116.08600. Epub 2017 Jan 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
June 4, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAL-200310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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