HypertensionNCT04015843
Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels
An observational study of Hypertension, run by China Cardiovascular Association at 1 site in China.
Trial summary
This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2019to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Initial diagnosis of primary hypertension
Who may be able to join
- Patients meeting the following criteria will be included:
- Age ≥18 years, male or female;
- Agreement for blood pressure and lipid testing;
- Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China [14] (with no antihypertensive drugs, SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;
- Willingness to participate in the study and signing of informed consent.
Who cannot join
- Patients meeting the following criteria will be excluded:
- Involvement in an interventional clinical research;
- Pregnancy or lactation in women;
- Complication with malignant tumors;
- Diagnosis of non-primary hypertension by researchers;
- Impaired cognitive ability;
- Researchers believing that the patients have other conditions not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei
Hu Daqing, MD
About this study
Official title: Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels: a Real-world Observational Study
This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.
Read the detailed description
The study aims to assess blood pressure and lipid levels, the use of lipid-lowering and antihypertensive drugs, and treatment compliance and adverse events in hypertensive outpatients of 30 hospitals of different levels, following them up for 1 and 3 months after treatment, respectively. The study would reveal the compliance of blood pressure and lipid levels in hypertensive patients under management of hospitals at different levels, and analyze factors affecting blood pressure or lipid levels associated with treatment compliance. Therefore, the study would provide clinical data from the real world for future prevention and control of CVD in China.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.
Blood pressure measurement:
Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.
Measured: 3 months
Secondary outcomes (5)
Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels
On a CardioChek dry-type biochemical analyzer, the levels of total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) in fingertip blood samples will be measured after 12-h fasting
Measured: 3 months
Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
Measured: 3 months
Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
Measured: 3 months
Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
Measured: 3 months
Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment
Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start22 Aug 2019
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Cardiovascular Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yong huo, master, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015843
- Sponsor's protocol ID
- GUSU18006
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2019
- Last updated
- 25 Nov 2019
- 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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Blood Pressure and Lipid in Hypertensive Patients Under the Management of Hospitals at Different Levels: a Real-world Observational Study
- ClinicalTrials.gov ID
- NCT04015843
- Acronym / sponsor ID
- GUSU18006
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- China Cardiovascular AssociationUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 11 Jul 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.
This is a multi-center, prospective cohort study that collects only diagnostic and therapeutic data in subjects but does not interfere with treatment.
Detailed description
The study aims to assess blood pressure and lipid levels, the use of lipid-lowering and antihypertensive drugs, and treatment compliance and adverse events in hypertensive outpatients of 30 hospitals of different levels, following them up for 1 and 3 months after treatment, respectively. The study would reveal the compliance of blood pressure and lipid levels in hypertensive patients under management of hospitals at different levels, and analyze factors affecting blood pressure or lipid levels associated with treatment compliance. Therefore, the study would provide clinical data from the real world for future prevention and control of CVD in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Initial diagnosis of primary hypertension
Key inclusion criteria (5 listed)
- Age ≥18 years, male or female;
- Agreement for blood pressure and lipid testing;
- Initial diagnosis of primary hypertension, with blood pressure conforming to the diagnostic criteria of the 2018 Guidelines for the Prevention and Treatment of Hypertension in China [14] (with no antihypertensive drugs, SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg after three tests performed on different days); or a history of primary hypertension but incompliant blood pressure;
- Willingness to participate in the study and signing of informed consent.
Key exclusion criteria (7 listed)
- Patients meeting the following criteria will be excluded:
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 primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels.
Time frame: 3 months
Blood pressure measurement: Blood pressure in both upper arms will be measured with a sphygmomanometer, with the patient in the sitting position. The mean value of three tests will be used for statistics. When left and right upper arms show different blood pressures, the higher value will be used for statistics.
5 secondary outcomes
Percentage of outpatients with abnormal blood lipid levels in hospitals at different levels
Time frame: 3 months
Achievement rate of blood lipid levels in hypertensive and dyslipidemic patients after 3 months of treatment in hospitals at different levels
Time frame: 3 months
Compliance of patients towards antihypertensive and lipid-lowering treatments in hospitals at different levels
Time frame: 3 months
Factors affecting blood pressure and lipid compliance in different hospitals, such as patient adverse events
Time frame: 3 months
Achievement rate of blood pressure in hypertensive patients under different levels of hospital management after 1 month of treatment
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- 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. This study is not recruiting at the moment.
yong huo, master principal investigator
Peking University First Hospital
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 Hypertension, run by China Cardiovascular Association 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei ma, doctor (13681050902, kmmawei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be compliance of blood pressure in hypertensive patients after 3 months of treatment in hospitals at different levels. (time frame: 3 months). 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 25 Nov 2019.