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Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Xuezhikang

Atorvastatin

Lifestyle modification

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Xuezhikang, atorvastatin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China

Exclusion Criteria:

Secondary Hypertension
Women who are pregnant or lactating
History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
Type 2 Diabetes
Active liver disease or impaired liver function tests
Impaired renal function
Uncontrolled cardiac arrhythmia
Patient who is unable to give informed consent
Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study

Sites / Locations

Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Normal-dose statin

Lifestyle modification + Xuezhikang

Lifestyle modification

Arm Description

Lifestyle modification with Normal-dose statin

Lifestyle changes with Xuezhikang

Lifestyle modification

Outcomes

Primary Outcome Measures

The primary endpoint is the Flow Mediated Dilatation (FMD)

Secondary Outcome Measures

the carotid - femoral Pulse Wave Velocity (cf-PWV),

inflammatory markers

lipid profiles

Full Information

NCT ID

NCT02254824

First Posted

April 17, 2014

Last Updated

September 29, 2014

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Peking University First Hospital, Peking Union Medical College Hospital, Beijing Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02254824

Brief Title

Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

Official Title

Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

Peking University First Hospital, Peking Union Medical College Hospital, Beijing Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

Detailed Description

EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

6. Conditions and Keywords

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

Hypertension

Keywords

Xuezhikang, atorvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal-dose statin

Arm Type

Active Comparator

Arm Description

Lifestyle modification with Normal-dose statin

Arm Title

Lifestyle modification + Xuezhikang

Arm Type

Active Comparator

Arm Description

Lifestyle changes with Xuezhikang

Arm Title

Lifestyle modification

Arm Type

Active Comparator

Arm Description

Lifestyle modification

Intervention Type

Drug

Intervention Name(s)

Xuezhikang

Intervention Description

Xuezhikang

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle modification

Intervention Description

Lifestyle modification

Primary Outcome Measure Information:

Title

The primary endpoint is the Flow Mediated Dilatation (FMD)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

the carotid - femoral Pulse Wave Velocity (cf-PWV),

Time Frame

1 year

Title

inflammatory markers

Time Frame

1 year

Title

lipid profiles

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China Exclusion Criteria: Secondary Hypertension Women who are pregnant or lactating History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy Type 2 Diabetes Active liver disease or impaired liver function tests Impaired renal function Uncontrolled cardiac arrhythmia Patient who is unable to give informed consent Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study

Central Contact Person:

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

Aimin - Dang, Doctor

Phone

0086-10-88398155

amdang@fuwaihospital.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aimin Dang, Doctor

Organizational Affiliation

Fuwai Hospital & Cardiovascular Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Naqiang Lv, Doctor

Phone

0086-10-13466500331

lvnaqiang@gmail.com

First Name & Middle Initial & Last Name & Degree

Aimin Dang, Doctor

12. IPD Sharing Statement

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Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

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