A Registry Study on the "Action of Controlling Ambulatory Blood Pressure to Target in Ten Thousand Patients"

September 27, 2021 updated by: Yan Li

24 hour ambulatory blood pressure (ABP) monitoring should be the first choice for diagnosis and treatment of hypertension according to European Societyof Hypertension (ESH) and the European Society of Cardiology (ESC) guideline on ambulatory blood pressure monitoring. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population.

Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Hypertension is the most common cardiovascular disease, and it is a fatal disease causing stroke, myocardial infarction and heart failure. Effective blood pressure management can greatly reduce the incidence of cardiovascular and cerebrovascular events. The control rate of hypertension in China is very severe. A national survey in 2002 showed that the control rate for hypertension was 6.1%. Another latest survey showed that among the 1.7 million Chinese aged 35 to 75, the detection rate of hypertension was 37 percent, among which the awareness rate and treatment rate and control rate were 36%, 23% and 6% respectively.

Traditionally, BP in the office or clinic has been assessed with the auscultatory technique, which has survived to this day in clinical practice. Although the technique is inherently accurate, it is dependent on observer attention to detail, which is lacking, and it provides only a momentary measurement of BP, usually under circumstances that can influence the level of BP being measured. To overcome these serious methodology problems, 24 hour ambulatory blood pressure techniques has been developed.

Ambulatory blood pressure monitoring is a major innovation in the development of hypertension diagnosis, and China has more than 20-year experience in clinical application of blood pressure monitoring. It measures blood pressure in a person's daily life and finds "masked hypertension", "white coat hypertension", "isolated nocturnal hypertension", "morning hypertension" and other special hypertension types. Compared with the office blood pressure, ambulatory blood pressure can better predict the incidence of target organ damage and cardiovascular events.

Ambulatory blood pressure monitoring not only can accurately assess blood pressure level, but also evaluate the effect of hypertensive therapy. Therefore, 24 hour ambulatory blood pressure monitoring should be the first choice for diagnosis and treatment of hypertension. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population.

Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic, and community sample

Description

Inclusion Criteria:

  • Age 18-80 years old
  • Clinical diagnosed hypertension with the use of antihypertensive drugs
  • A 24-hour ambulatory blood pressure monitoring was performed with validated equipment.
  • Willing to provide information about disease history and blood biochemical test data within 6 months.
  • Sign the informed consent

Exclusion Criteria:

  • Without antihypertensive drug use
  • Hospitalized hypertension patients
  • Non-compliant patient

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
Composite end point of major cardiovascular and cerebrovascular events
Time Frame: From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years
Composite end point of major cardiovascular and cerebrovascular events
From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The control rate of clinic blood pressure
Time Frame: From date of enrollment until study completion,an average of 3 years
From date of enrollment until study completion,an average of 3 years
The control rate of 24-hour ambulatory blood pressure
Time Frame: From date of enrollment until study completion,an average of 3 years
From date of enrollment until study completion,an average of 3 years
the proportion of white-coat uncontrolled hypertension
Time Frame: From date of enrollment until study completion,an average of 3 years
From date of enrollment until study completion,an average of 3 years
the proportion of masked uncontrolled hypertension
Time Frame: From date of enrollment until study completion,an average of 3 years
From date of enrollment until study completion,an average of 3 years
The occurrence time of cardiovascular events in different groups
Time Frame: From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years
From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years

Collaborators and Investigators

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

Sponsor

Yan Li

Investigators

  • Principal Investigator: Yan Li, Shanghai Institute of Hypertension

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 (Actual)

July 18, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REACTION-ABP

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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