Valsartan in Elderly Isolated Systolic Hypertension Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Valsartan in Elderly Isolated Systolic Hypertension

Conditions
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Aged, Systolic Hypertension

Intervention / Treatment
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* Other: target blood pressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: strict control<br>systolic blood pressure control: less than 140 mm Hg | Other: target blood pressure<br> <br> |
| Active Comparator: moderate control<br>systolic blood pressure control: 140 mm Hg to 149 mm Hg | Other: target blood pressure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sudden death |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 
| stroke |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 
| myocardial infarction |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 
| heart failure |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 
| hospitalization |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 
| renal disorder |  | participants will be followed for the duration of the study, an expected median follow-up 3.07 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isolated systolic hypertension, valsartan, target blood pressure