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NCT Number: NCT04137549

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

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.

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Key information

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Yan Li, Professor

CONTACT

[email protected]

021-64370045 ext. 663228

Yan Li, Professor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The occurrence time of fatal and non-fatal cardiovascular events.

    Time frame: 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 outcomes

  1. The occurrence time of all-cause mortality.

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

  2. The occurrence time of fatal and nonfatal stroke.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Li, MD,PhD

CONTACT

[email protected]

0086-021-64370045 ext. 663201

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Hypertension

Other

Registry information

Official study title

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

Acronym: CONTROL-NHT

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2019
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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