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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nocturnal Hypertension

• Study Type: Observational
• Enrollment (Anticipated): 4500

Contacts and Locations

• Study Contact: Name: Yan Li, MD,PhD; Phone Number: 663201 0086-021-64370045; Email: liyanshcn@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, and community sample

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Hypertension

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ambulatory blood pressure monitoring; cardiovascular risk; nocturnal hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CONTROL-NHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No