Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study) (KACT)

Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.

• Blood pressure control
• Changing of adiponectin and plasminogen activator inhibitor-1
• Influence metabolizing and cardiac function, etc.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Obesity
• Intervention / Treatment: Drug: Valsartan

Detailed Description

The primary endpoints are:

• blood pressure control
• Adiponectin and plasma type1 plasminogen active inhibitor

The secondary endpoints are

• HOMA-IR
• HbA1c
• TNF-α
• IL-6
• Plasma B-type natriuretic peptide
• LVMI
• E/A ratio
• Tei-index
• Apo-J

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chuwa Tei, MD, PhD; Email: tei@m.kufm.kagoshima-u.ac.jp
• Study Contact Backup: Name: Masaaki Miyata, MD, PhD; Phone Number: ＋81-99-275-5318; Email: miyatam@m3.kufm.kagoshima-u.ac.jp

Study Locations

• Japan
  • Kagoshima, Japan, 890-8520
    • Recruiting
    • Chuwa Tei,MD,FACC,FAHA
    • Contact: Chuwa Tei, MD,FACC,FAHA; Email: tei@m.kufm.kagoshima-u.ac.jp
    • Contact: Masaaki Miyata, MD,PhD、FACC; Email: miyatam@m3.kufm.kagoshima-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Out patients with hypertension male and female
• Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
• Waist Surrounding diameter male≧85cm female≧90cm
• Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
• Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl
• Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion Criteria:

• Patient who is using ACE-I and ARB
• Serum creatinine ≧ 3 mg/dl
• Liver impairment
• History of allergy to valsartan
• Pregnant women
• Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Valsartan; Valsartan 80 to 160mg	Drug: Valsartan; Valsartan 80 to 160 mg
No Intervention: standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure, Adiponectin and PAI-1 concentration	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
HbA1c	1 year
HOMA-IR	1 year
TNF-α	１ year
IL-6	1 year
BNP	1 year
LVMI	1 year
E/A ratio	1 year
Tei-index	1 year
Apo-J	1 year

Collaborators and Investigators

• Sponsor: Kagoshima University
• Investigators: Study Chair: Chuwa Tei, MD, PhD, Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University

Publications and helpful links

General Publications

• Miyata M, Ikeda Y, Nakamura S, Sasaki T, Abe S, Minagoe S, Torii H, Lee S, Tateishi S, Kihara K, Ohba I, Kajiya S, Furusho Y, Hamasaki S, Tei C; Kagoshima Collaborate Trial in Metabolic Syndrome (KACT-MetS) Investigators. Effects of valsartan on fibrinolysis in hypertensive patients with metabolic syndrome. Circ J. 2012;76(4):843-51. doi: 10.1253/circj.cj-12-0153.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: October 10, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (Estimate): November 14, 2008

Study Record Updates

• Last Update Posted (Estimate): June 3, 2010
• Last Update Submitted That Met QC Criteria: June 2, 2010
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: Metabolic syndrome; valsartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Hypertension; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: CVM-RCT-2006-06