Community-based Microalbuminuria Screening in Patients With Hypertension (CMSIH)

July 24, 2018 updated by: Xuejuan Jin, Shanghai Zhongshan Hospital

Effectiveness of Different Antihypertensive Medications on Urine Albumin-to-Creatinine Ratio (UACR) in Community Hypertensive Patients With Microalbuminuria

This study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria.

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a a real world registry study. All patients with hypertension in community hospitals in China will be eligible . Patient demographics, medical history, clinical characteristics, physical examination, laboratory tests (including UCAR, blood routine, urine routine, blood biochemistry, and ECG), antihypertensive drugs (including: ACEI/ ARB, thiazide diuretics, CCB, beta-blockers, alpha-blockers, and other antihypertensive drugs used in real-life clinical practice in other communities.) will be recorded. All patients are anticipated to be followed up for 12-month. Effectiveness of different antihypertensive medications on Urine Albumin-to-Creatinine Ratio (UACR) will be evaluted.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community Hypertensive Patients With Microalbuminuria

Description

Inclusion Criteria:

  • Patients with essential hypertension;
  • Urinary albumin/creatinine ratio in random urine samples is 30-300 mg/g
  • Age >=18
  • Understand and sign informed consent

Exclusion Criteria:

  • This is a real-world registry study and does not set exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Albumin-to-Creatinine Ratio (UCAR)
Time Frame: 12 months
Differences in UCAR between with ACEI/ARB and without ACEI/ARB
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined endpoints: re-admission, cardiovascular events, and all-cause mortality
Time Frame: 12 months
Differences in Combined endpoints between with ACEI/ARB and without ACEI/ARB
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2018-106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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