Registry Study on "Control Nocturnal Hypertension to Reach the Target "

Nocturnal Hypertension Clinical Trial

— CONTROL-NHT  

Official title:

Registry Study on "Control Nocturnal Hypertension to Reach the Target "（CONTROL-NHT）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137549
• Other study ID #: CONTROL-NHT
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: Shanghai Institute of Hypertension
• Contact: Yan Li, MD,PhD
• Phone: 0086-021-64370045
• Email: liyanshcn[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Ambulatory blood pressure monitoring (ABPM) is a major innovation in the history of hypertension diagnosis. In clinical practice, the most well established indication for using ABPM is to identify patients who have high BP readings in the office but normal readings during usual daily activities outside of this setting or vice versa, and to identify varying 24-h BP profiles. However, in recent years, there has been increasing interest in BP values during sleep, and nocturnal BP is now recognized to be superior to daytime BP in predicting fatal and nonfatal cardiovascular events (stroke, myocardial infarction, and cardiovascular death), especially in medicated patients.

The current direction in the management of hypertension is toward earlier and lower BP control for 24 hours, including the nocturnal and morning periods. Therefore, it may be of great significance to pay attention to the management of nocturnal blood pressure so as to reduce the increased cardiovascular risks.

Information of nocturnal hypertensive patients defined by ABPM was prospectively registered nationwide, and then to investigate whether there was difference in cardiovascular prognosis according to the control of ambulatory nocturnal blood pressure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age 50-79 years old

• Clinical diagnosed hypertension with the use of antihypertensive drugs

• Nocturnal hypertension ( nocturnal systolic blood pressure = 130 mmHg and/or nocturnal diastolic blood pressure = 80 mmHg)

• 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

• Hypertension
• Nocturnal Hypertension

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Hypertension

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence time of fatal and non-fatal cardiovascular events.	Fatal and non-fatal cardiovascular events, including cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, coronary artery bypass grafting or interventional stenting or balloon dilation, and hospitalization for heart failure.	From date of enrollment until date of first documented event assessed up to 3 years
Secondary	The occurrence time of all-cause mortality.		From date of enrollment until date of first documented event, assessed up to 3 years
Secondary	The occurrence time of fatal and nonfatal stroke.		From date of enrollment until date of first documented event assessed up to 3 years