Cardiovascular Risk FactorNCT04531124
Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives
An observational study of Cardiovascular Risk Factor and Hypertension, run by Huashan Hospital at 1 site in China.
Trial summary
this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Risk Factor, Hypertension, Renal Disease
- What is being tested?
- integrated management
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 28 Feb 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients with hypertension in different levels of hospitals in Shanghai, 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.
About this study
Official title: Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives：a Multicenter Prospective Cohort Study （UPDATE-cohort）
this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.
- Conditions
- Cardiovascular Risk Factor, Hypertension, Renal Disease
- Being tested
- integrated management
- Medical subject headings
- Hypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated managementOther
establish an integrated management on cardio-metabolic risk factors including hypertension by updating and upgrading the daily practice of practitioners and screening patients
| Study group | Role | What they receive |
|---|---|---|
| control group without an integrated management | Not described | |
| observational group with an integrated management | Not described Receives: Other: integrated management |
What is being measured
The primary outcome is the main question the study is designed to answer.
complex outcome
number of participants with 3P-MACE events(cardiovascular deaths, non-fatal myocardial infarction, non-fatal stroke)
Measured: follow-up 1 year
coronary angioplasty
number of participants with coronary angioplasty
Measured: follow-up 1 year
acute renal failure
number of participants with acute renal failure(eGFR decreases by 50% or <15ml/min/1.73m2, dialysis or renal death)
Measured: follow-up 1 year
acute heart failure
number of participants with acute heart failure(non-scheduled hospitalizations due to heart failure or required intravenous medication)
Measured: follow-up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- 30,000 participants (estimated)
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
- NCT04531124
- Sponsor's protocol ID
- Huashan cardiology
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives：a Multicenter Prospective Cohort Study （UPDATE-cohort）
- ClinicalTrials.gov ID
- NCT04531124
- Acronym / sponsor ID
- Huashan cardiology
- Conditions
- Cardiovascular Risk Factor, Hypertension, Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 28 Aug 2020 (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 clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group without an integrated management | – | – |
| observational group with an integrated management | – | Other: integrated management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients with hypertension in different levels of hospitals in Shanghai, 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 |
|---|---|---|
| integrated managementestablish an integrated management on cardio-metabolic risk factors including hypertension by updating and upgrading the daily practice of practitioners and screening patients | Other | observational group with an integrated management |
Primary outcome
complex outcome
Time frame: follow-up 1 year
number of participants with 3P-MACE events(cardiovascular deaths, non-fatal myocardial infarction, non-fatal stroke)
coronary angioplasty
Time frame: follow-up 1 year
number of participants with coronary angioplasty
acute renal failure
Time frame: follow-up 1 year
number of participants with acute renal failure(eGFR decreases by 50% or <15ml/min/1.73m2, dialysis or renal death)
acute heart failure
Time frame: follow-up 1 year
number of participants with acute heart failure(non-scheduled hospitalizations due to heart failure or required intravenous medication)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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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 Cardiovascular Risk Factor and Hypertension, 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 28 Aug 2020. 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 yong li, professor (+86 13801753494 ext. china shanghai, liyong606@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complex outcome (time frame: follow-up 1 year). The study lists 4 primary outcomes in all. 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 28 Aug 2020.