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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03547856
• Other study ID #: REACTION-ABP
• Status: Recruiting
• Start date: July 18, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, Professor
• Phone: 021-64370045
• Email: liyanshcn[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Hypertension

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yan Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end point of major cardiovascular and cerebrovascular events	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	The control rate of clinic blood pressure		From date of enrollment until study completion,an average of 3 years
Secondary	The control rate of 24-hour ambulatory blood pressure		From date of enrollment until study completion,an average of 3 years
Secondary	the proportion of white-coat uncontrolled hypertension		From date of enrollment until study completion,an average of 3 years
Secondary	the proportion of masked uncontrolled hypertension		From date of enrollment until study completion,an average of 3 years
Secondary	The occurrence time of cardiovascular events in different groups		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