Clinical trial NCT04137549: Registry Study on "Control Nocturnal Hypertension to Reach the Target "
Official title: Registry Study on "Control Nocturnal Hypertension to Reach the Target "（CONTROL-NHT）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nocturnal Hypertension
Keywords: ambulatory blood pressure monitoring
nocturnal hypertension
cardiovascular risk
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 4500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, and community sample

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.


Eligibility criteria: 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

Primary outcomes:
measure: The occurrence time of fatal and non-fatal cardiovascular events.
timeFrame: From date of enrollment until date of first documented event assessed up to 3 years
Secondary outcomes:
measure: The occurrence time of all-cause mortality.
timeFrame: From date of enrollment until date of first documented event, assessed up to 3 years
measure: The occurrence time of fatal and nonfatal stroke.
timeFrame: From date of enrollment until date of first documented event assessed up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: