HypertensionNCT03862183
Hospital-level Variation in the Management of Blood Pressure and Low-density Lipoprotein in the Outpatient Hypertensives in China-a Cross Sectional Study
An observational study of Hypertension and Hyperlipidemia, run by Huashan Hospital at 1 site in China.
Trial summary
To investigate the proportion, medication use and control rate of metabolic abnormalities such as dyslipidemia in outpatients with hypertension in different levels of hospitals in China. To investigate the gap between guidelines and clinical practices, and analyze the cause. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- continuing medical education program
- How many people
- 21,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Dec 2020
- How long will I take part?
- 3 Years
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients with hypertension in different levels of hospitals in China
Who may be able to join
- Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
- Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
- Voluntary participation.
Who cannot join
- Patients aged< 18 years old.
- Patients without a definite diagnosis of hypertension（for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension）.
- Patients with a definite diagnosis of secondary hypertension.
- Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
- Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
- Patients diagnosed with mental abnormalities who are unable to complete the questionnaire.
- Patients have once participated in this research during this study cycle（to avoid repeated participation）.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiology Department in Huashan Hospital
Shanghai, Shanghai Municipality, 200036
Xiufang Gao, PhD
About this study
Official title: Survey on BP, Lipids and Cardiovascular Risks in the Outpatient Hypertensives and Continuing Medical Education Program
To investigate the proportion, medication use and control rate of metabolic abnormalities such as dyslipidemia in outpatients with hypertension in different levels of hospitals in China. To investigate the gap between guidelines and clinical practices, and analyze the cause. we also set up a continuing medical education program to narrow the gap and the effect of the program will be estimated.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- continuing medical education program
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuing medical education programOther
educating all the involved doctor the same medical knowledge on hypertension control
| Study group | Role | What they receive |
|---|---|---|
| dyslipidemia in hypertension | Not described Receives: Other: continuing medical education program | |
| hypertension | Not described Receives: Other: continuing medical education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of blood pressure goal achievement
systolic blood pressure<140mmHg and diastolic blood pressure<90mmHg
Measured: 2017-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jul 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- 21,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Li, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862183
- Sponsor's protocol ID
- UPPDATE
- Status last verified
- Mar 2019
- First submitted
- 2 Mar 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie K, Gao X, Bao L, Shan Y, Shi H, Li Y. The different risk factors for isolated diastolic hypertension and isolated systolic hypertension: a national survey. BMC Public Health. 2021 Sep 14;21(1):1672. doi: 10.1186/s12889-021-11686-9.
PubMed 34521364
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on BP, Lipids and Cardiovascular Risks in the Outpatient Hypertensives and Continuing Medical Education Program
- ClinicalTrials.gov ID
- NCT03862183
- Acronym / sponsor ID
- UPPDATE
- Conditions
- Hypertension, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 5 Mar 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.
To investigate the proportion, medication use and control rate of metabolic abnormalities such as dyslipidemia in outpatients with hypertension in different levels of hospitals in China. To investigate the gap between guidelines and clinical practices, and analyze the cause. we also set up a continuing medical education program to narrow the gap and the effect of the program will be estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dyslipidemia in hypertension | – | Other: continuing medical education program |
| hypertension | – | Other: continuing medical education program |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients with hypertension in different levels of hospitals in China
Key inclusion criteria (3 listed)
- Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
- Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
- Voluntary participation.
Key exclusion criteria (7 listed)
- Patients aged< 18 years old.
- Patients without a definite diagnosis of hypertension（for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension）.
- Patients with a definite diagnosis of secondary hypertension.
- Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
- Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuing medical education programeducating all the involved doctor the same medical knowledge on hypertension control | Other | dyslipidemia in hypertension, hypertension |
Primary outcome
rate of blood pressure goal achievement
Time frame: 2017-2020
systolic blood pressure<140mmHg and diastolic blood pressure<90mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 34521364Xie K, Gao X, Bao L, Shan Y, Shi H, Li Y. The different risk factors for isolated diastolic hypertension and isolated systolic hypertension: a national survey. BMC Public Health. 2021 Sep 14;21(1):1672. doi: 10.1186/s12889-021-11686-9.
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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.
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 and Hyperlipidemia, run by Huashan Hospital 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 3 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 5 Mar 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 xiufang gao, PhD (+86 13788908071, sophiakao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of blood pressure goal achievement (time frame: 2017-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862183, which also lists 1 linked publication.
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 5 Mar 2019.