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

Primary Purpose

Hypertension, Obesity

Status

Unknown status

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Valsartan

About this trial

This is an interventional prevention trial for Hypertension focused on measuring valsartan, Metabolic syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chuwa Tei,MD,FACC,FAHARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Valsartan

standard therapy

Arm Description

Valsartan 80 to 160mg

Outcomes

Primary Outcome Measures

Blood Pressure, Adiponectin and PAI-1 concentration

Secondary Outcome Measures

HOMA-IR

HbA1c

TNF-α

IL-6

BNP

LVMI

E/A ratio

Tei-index

Apo-J

Full Information

NCT ID

NCT00790946

First Posted

October 10, 2008

Last Updated

June 2, 2010

Sponsor

Kagoshima University

1. Study Identification

Unique Protocol Identification Number

NCT00790946

Brief Title

Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Acronym

KACT

Official Title

Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Kagoshima University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Obesity

Keywords

valsartan, Metabolic syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valsartan

Arm Type

Active Comparator

Arm Description

Valsartan 80 to 160mg

Arm Title

standard therapy

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Description

Valsartan 80 to 160 mg

Primary Outcome Measure Information:

Title

Blood Pressure, Adiponectin and PAI-1 concentration

Time Frame

1 year

Secondary Outcome Measure Information:

Title

HOMA-IR

Time Frame

1 year

Title

HbA1c

Time Frame

1 year

Title

TNF-α

Time Frame

１ year

Title

IL-6

Time Frame

1 year

Title

BNP

Time Frame

1 year

Title

LVMI

Time Frame

1 year

Title

E/A ratio

Time Frame

1 year

Title

Tei-index

Time Frame

1 year

Title

Apo-J

Time Frame

1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chuwa Tei, MD, PhD

tei@m.kufm.kagoshima-u.ac.jp

First Name & Middle Initial & Last Name or Official Title & Degree

Masaaki Miyata, MD, PhD

Phone

＋81-99-275-5318

miyatam@m3.kufm.kagoshima-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chuwa Tei, MD, PhD

Organizational Affiliation

Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University

Official's Role

Study Chair

Facility Information:

Facility Name

Chuwa Tei,MD,FACC,FAHA

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuwa Tei, MD,FACC,FAHA

tei@m.kufm.kagoshima-u.ac.jp

First Name & Middle Initial & Last Name & Degree

Masaaki Miyata, MD,PhD、FACC

miyatam@m3.kufm.kagoshima-u.ac.jp

12. IPD Sharing Statement

Citations:

PubMed Identifier

22451451

Citation

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.

Results Reference

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Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

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