Valsartan in Elderly Isolated Systolic Hypertension Study

NCT00151229 | Completed Phase 4 DMC

• 1 other identifier: VAL-200310
• Study Type: interventional
• Target: 3,079
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged; Systolic Hypertension

Keywords

isolated systolic hypertension; valsartan; target blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

strict control

ACTIVE COMPARATOR

systolic blood pressure control: less than 140 mm Hg

Other: target blood pressure

moderate control

ACTIVE COMPARATOR

systolic blood pressure control: 140 mm Hg to 149 mm Hg

Other: target blood pressure

Interventions

target blood pressure OTHER

moderate control; strict control

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VALISH study: lead
• Japan Cardiovascular Research Foundation: collaborator

Study Sites (1)

VALISH Data Center

ING Corporation, 8-21, Shinjuku-ku, Tokyo, 162-0067, Japan

Location

Related Publications (3)

• 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.

  PMID: 15750259 BACKGROUND

• 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.

  PMID: 20530299 RESULT

• 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.

  PMID: 28049699 DERIVED

MeSH Terms

Conditions

Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: October 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

JP (1)