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

Recruiting

• Conditions: Nocturnal Hypertension

• Registration Number: NCT04137549
• Lead Sponsor: Shanghai Institute of Hypertension

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence time of fatal and non-fatal cardiovascular events.	From date of enrollment until date of first documented event assessed up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
The occurrence time of fatal and nonfatal stroke.	From date of enrollment until date of first documented event assessed up to 3 years
The occurrence time of all-cause mortality.	From date of enrollment until date of first documented event, assessed up to 3 years

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China