Clinical trial NCT00151229: Valsartan in Elderly Isolated Systolic Hypertension Study
Official title: Valsartan in Elderly Isolated Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aged
Systolic Hypertension
Keywords: isolated systolic hypertension
valsartan
target blood pressure
Lead sponsor: VALISH study
Sponsor class: OTHER
Collaborators: name: Japan Cardiovascular Research Foundation
First posted: 2005-09-08
Enrollment: 3079
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: composite cardiovascular events
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
Secondary outcomes:
measure: sudden death
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
measure: stroke
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
measure: myocardial infarction
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
measure: heart failure
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
measure: hospitalization
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
measure: renal disorder
timeFrame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
Other outcomes:
Locations:
city: ING Corporation, 8-21, Shinjuku-ku
country: Japan
facility: VALISH Data Center
state: Tokyo
Study officials:
affiliation: Department of Geriatric Medicine, Osaka University Graduate School of Medicine
name: Toshio Ogihara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Keio University School of Medicine
name: Takao Saruta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 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.
citation: 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.