HypertensionCMSIHNCT03596840
Community-based Microalbuminuria Screening in Patients With Hypertension
An observational study of Hypertension and Microalbuminuria, run by Shanghai Zhongshan Hospital.
Trial summary
This study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Microalbuminuria
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 31 Dec 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: Community Hypertensive Patients With Microalbuminuria
Who may be able to join
- Patients with essential hypertension;
- Urinary albumin/creatinine ratio in random urine samples is 30-300 mg/g
- Age >=18
- Understand and sign informed consent
Who cannot join
- This is a real-world registry study and does not set exclusion criteria
Trial locations and contacts
No sites are listed yet.
Wei Zhang, phD contact
About this study
Official title: Effectiveness of Different Antihypertensive Medications on Urine Albumin-to-Creatinine Ratio (UACR) in Community Hypertensive Patients With Microalbuminuria
This study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria.
Read the detailed description
This is a a real world registry study. All patients with hypertension in community hospitals in China will be eligible . Patient demographics, medical history, clinical characteristics, physical examination, laboratory tests (including UCAR, blood routine, urine routine, blood biochemistry, and ECG), antihypertensive drugs (including: ACEI/ ARB, thiazide diuretics, CCB, beta-blockers, alpha-blockers, and other antihypertensive drugs used in real-life clinical practice in other communities.) will be recorded. All patients are anticipated to be followed up for 12-month. Effectiveness of different antihypertensive medications on Urine Albumin-to-Creatinine Ratio (UACR) will be evaluted.
- Conditions
- Hypertension, Microalbuminuria
- Keywords
- Hypertension, Microalbuminuria, Effectiveness, Antihypertensive medications
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Albumin-to-Creatinine Ratio (UCAR)
Differences in UCAR between with ACEI/ARB and without ACEI/ARB
Measured: 12 months
Secondary outcomes (1)
Combined endpoints: re-admission, cardiovascular events, and all-cause mortality
Differences in Combined endpoints between with ACEI/ARB and without ACEI/ARB
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 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.
- More trials run by Shanghai Zhongshan 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuejuan Jin, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596840
- Sponsor's protocol ID
- B2018-106
- Acronym
- CMSIH
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 26 Jul 2018
- 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Antihypertensive Medications on Urine Albumin-to-Creatinine Ratio (UACR) in Community Hypertensive Patients With Microalbuminuria
- ClinicalTrials.gov ID
- NCT03596840
- Acronym / sponsor ID
- CMSIH / B2018-106
- Conditions
- Hypertension, Microalbuminuria
- Keywords
- Hypertension, Microalbuminuria, Effectiveness, Antihypertensive medications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Jul 2018 (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 study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria.
Detailed description
This is a a real world registry study. All patients with hypertension in community hospitals in China will be eligible . Patient demographics, medical history, clinical characteristics, physical examination, laboratory tests (including UCAR, blood routine, urine routine, blood biochemistry, and ECG), antihypertensive drugs (including: ACEI/ ARB, thiazide diuretics, CCB, beta-blockers, alpha-blockers, and other antihypertensive drugs used in real-life clinical practice in other communities.) will be recorded. All patients are anticipated to be followed up for 12-month. Effectiveness of different antihypertensive medications on Urine Albumin-to-Creatinine Ratio (UACR) will be evaluted.
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
- Community Hypertensive Patients With Microalbuminuria
Key inclusion criteria (4 listed)
- Patients with essential hypertension;
- Urinary albumin/creatinine ratio in random urine samples is 30-300 mg/g
- Age >=18
- Understand and sign informed consent
Key exclusion criteria (1 listed)
- This is a real-world registry study and does not set exclusion criteria
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
Urine Albumin-to-Creatinine Ratio (UCAR)
Time frame: 12 months
Differences in UCAR between with ACEI/ARB and without ACEI/ARB
1 secondary outcome
Combined endpoints: re-admission, cardiovascular events, and all-cause mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Wei Zhang, phD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Microalbuminuria, run by Shanghai Zhongshan Hospital.
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 4 inclusion and 1 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Xuejuan Jin, MS (+86-13681973269, jin.xuejuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Albumin-to-Creatinine Ratio (UCAR) (time frame: 12 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 26 Jul 2018.