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

NCT04137549 | Recruiting

• 1 other identifier: CONTROL-NHT
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Hypertension

Keywords

ambulatory blood pressure monitoring; nocturnal hypertension; cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The occurrence time of all-cause mortality.

  From date of enrollment until date of first documented event, assessed up to 3 years

• The occurrence time of fatal and nonfatal stroke.

  From date of enrollment until date of first documented event assessed up to 3 years

Study Arms (2)

Nocturnal controlled hypertension

Nocturnal blood pressure was controlled under 120/70 mmHg after aggressive anti-hypertensive therapy.

Nocturnal uncontrolled hypertension

Nocturnal blood pressure was still over 120/70 mmHg after aggressive anti-hypertensive therapy.

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, and community sample

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Institute of Hypertension: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Central Study Contacts

Yan Li, MD,PhD

CONTACT

0086-021-64370045; liyanshcn@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: December 1, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)