Valsartan in Elderly Isolated Systolic Hypertension Study

Aged Clinical Trial

— VALISH  

Official title:

Valsartan in Elderly Isolated Systolic Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151229
• Other study ID #: VAL-200310
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: June 3, 2015
• Start date: October 2003
• Est. completion date: March 2008

Study information

• Verified date: June 2015
• Source: VALISH study
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3079
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Aged
• Hypertension
• Systolic Hypertension

Intervention

Other:
• target blood pressure

Locations

Country	Name	City	State
Japan	VALISH Data Center	ING Corporation, 8-21, Shinjuku-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
VALISH study	Japan Cardiovascular Research Foundation

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. Review. — View Citation

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 isola — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite cardiovascular events	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	Yes
Secondary	sudden death		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes
Secondary	stroke		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes
Secondary	myocardial infarction		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes
Secondary	heart failure		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes
Secondary	hospitalization		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes
Secondary	renal disorder		participants will be followed for the duration of the study, an expected median follow-up 3.07 years	Yes