Pre-EclampsiaNCT03200743
Catestatin and Hypertension in Pregnancy
An observational study of Pre-Eclampsia and Eclampsia, run by Yuchen Pan at 1 site in China.
Trial summary
Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2017to Dec 2017
- How long will I take part?
- 18 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients hospitalized in Peking University Third Hospital maternity ward after May, 2017
Who may be able to join
- Healthy pregnancy women
- Pregnancy women with hypertension
- Despite the pregnant gestational age , systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured three times more than 24 hours apart
- Pregnant gestational age > 20 weeks, systolic blood pressure ≥140 mm Hg OR a diastolic blood pressure of ≥90 mm Hg measured twice more than 4 hours apart
Who cannot join
- Lack of blood sample at the specified enrollment period
- Women who refuse the study
- Other illness which needs medications interfering with blood pressure (eg: Asthma requiring systemic steroids)
- Known coronary artery disease or heart failure
- Serious medical illness (eg: renal insufficiency, congestive heart disease, chronic respiratory insufficiency, uncontrolled infection).
- multiple endocrine neoplasia or Cushing's syndrome or mixed tumours or pheochromocytoma or medullary thyroid carcinoma.
- previous history of malignant tumour, with the exception of carcinoma in situ of the uterine cervix or non-melanoma skin cancer
- renal insufficiency
Trial locations and contacts
1 site in 1 country.
Dan Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijin, Beijing Municipality, 100191
Yuchen Pan, MD, +8618810533382, panyuchen@bjmu.edu.cn
Dan Zhu, MD, andrea_zhu@163.com
About this study
Official title: Relationship Between Catestatin and Pregnant Hypertensive Disorders
Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with hypertension, the research may contribute to this problem.
- Keywords
- Hypertension, Pregnancy, Catestatin
- Medical subject headings
- Pre-Eclampsia, Eclampsia, Hypertension, Pregnancy-Induced, Hypertension
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 |
|---|---|---|
| Hpertension | Not described | |
| Health | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma level of Catestatin
plasma level of Catestatin with the unit "mmol/l"
Measured: once at the specified enrollment period
Secondary outcomes (1)
blood pressure
systolic and diastolic blood pressure with the unit "mmHg"
Measured: the specified enrollment period,42 days and 2 months after the pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start14 May 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Yuchen Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuchen Pan, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200743
- Sponsor's protocol ID
- 20170513
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Catestatin and Pregnant Hypertensive Disorders
- ClinicalTrials.gov ID
- NCT03200743
- Acronym / sponsor ID
- 20170513
- Keywords
- Hypertension, Pregnancy, Catestatin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yuchen PanUniversity, hospital or other
- Study start
- 14 May 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jun 2017 (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.
Catestatin is a kind of protein involved with cardiovascular disease. Accumulated evidence shows that Catestatin may be a predictor of primary hypertension, but whether it plays the same role in pregnant hypertensive disorders needs to be determined. By measuring the plasma level of Catestatin, main biochemical marks and UCG in healthy pregnancy and pregnancy with hypertension, the research may contribute to this problem.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hpertension | – | – |
| Health | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in Peking University Third Hospital maternity ward after May, 2017
Key inclusion criteria (4 listed)
- Healthy pregnancy women
- Pregnancy women with hypertension
Key exclusion criteria (8 listed)
- Lack of blood sample at the specified enrollment period
- Women who refuse the study
- Other illness which needs medications interfering with blood pressure (eg: Asthma requiring systemic steroids)
- Known coronary artery disease or heart failure
- Serious medical illness (eg: renal insufficiency, congestive heart disease, chronic respiratory insufficiency, uncontrolled infection).
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
plasma level of Catestatin
Time frame: once at the specified enrollment period
plasma level of Catestatin with the unit "mmol/l"
1 secondary outcome
blood pressure
Time frame: the specified enrollment period,42 days and 2 months after the pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Dan Zhu, MD contact
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 Pre-Eclampsia and Eclampsia, run by Yuchen Pan 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 4 inclusion and 8 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 27 Jun 2017. 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 Yuchen Pan, MD (+8618810533382, panyuchen@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma level of Catestatin (time frame: once at the specified enrollment period). 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 27 Jun 2017.