Nocturnal HypertensionCONTROL-NHTNCT04137549
Registry Study on "Control Nocturnal Hypertension to Reach the Target "
An observational study of Nocturnal Hypertension, run by Shanghai Institute of Hypertension at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Nocturnal Hypertension
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, and community sample
Who may be able to join
- 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
Who cannot join
- Without antihypertensive drug use
- Hospitalized hypertension patients
- Non-compliant patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Yan Li, Professor, 021-64370045 ext. 663228, liyanshcn@yahoo.com
Yan Li, Professor
About this study
Official title: 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.
- Conditions
- Nocturnal Hypertension
- Keywords
- ambulatory blood pressure monitoring, nocturnal hypertension, cardiovascular risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From date of enrollment until date of first documented event, assessed up to 3 years
The occurrence time of fatal and nonfatal stroke.
Measured: From date of enrollment until date of first documented event assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Dec 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Hypertension
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137549
- Sponsor's protocol ID
- CONTROL-NHT
- Acronym
- CONTROL-NHT
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2019
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on "Control Nocturnal Hypertension to Reach the Target "（CONTROL-NHT）
- ClinicalTrials.gov ID
- NCT04137549
- Acronym / sponsor ID
- CONTROL-NHT / CONTROL-NHT
- Conditions
- Nocturnal Hypertension
- Keywords
- ambulatory blood pressure monitoring, nocturnal hypertension, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Shanghai Institute of HypertensionUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, and community sample
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Without antihypertensive drug use
- Hospitalized hypertension patients
- Non-compliant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The occurrence time of all-cause mortality.
Time frame: From date of enrollment until date of first documented event, assessed up to 3 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Hypertension, run by Shanghai Institute of Hypertension at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, MD,PhD (0086-021-64370045 ext. 663201, liyanshcn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.