- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05149781
Standardized Diagnosis and Treatment of Endocrine Hypertension
September 12, 2023 updated by: Affiliated Hospital of Nantong University
Cases of endocrine hypertension or primary hypertension who have signed informed consent will be collected.
Patients with endocrine hypertension will be divided into surgical treatment group and drug treatment group according to actual treatment situation.
A database will be established for all patients.
The investigators will comprehensively evaluate the general conditions, past medical history, metabolic and biochemical indicators, psychological status, cardiovascular risk factors.
All the patients will be followed up for 12 months at baseline, 6 months and 12 months.
Clinical data and specimen will be collected.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators will collect 100 patients with secretory hypertension and 100 patients with essential hypertension.
Patients with endocrine hypertension will be divided into surgical treatment group and drug treatment group according to actual treatment situation.
Resected specimens from surgical patients will be used for immunohistochemistry and western blot.
A database will be established for all patients to assess their general situation, past medical history, metabolic and biochemical indicators, psychological status, cardiovascular risk factors, etc.
The investigators expect to find more accurate screening indicators from blood and urine specimens.
All the patients will be followed up for 12 months at baseline, 6 months and 12 months.
Blood pressure, degree of atherosclerosis, biochemical markers, hormone levels and cardiac function indicators will be measured at three time points.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gu Yunjuan, M.D/Ph.D
- Phone Number: +8615851207860
- Email: desette@ntu.edu.cn
Study Locations
-
-
Jiangsu
-
Nantong, Jiangsu, China, 226001
- Recruiting
- Gu Yunjuan
-
Contact:
- Gu Yunjuan, M.D/Ph.D
- Phone Number: +8615851207860
- Email: desette@ntu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with endocrine hypertension or primary hypertension treated at Affiliated Hospital of Nantong University between 2021 and 2024
Description
Inclusion Criteria:
age≥18 years
Exclusion Criteria:
- myocardial infarction
- congestive heart failure
- stroke
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with EH
patients with endocrine hypertension
|
Patients with endocrine hypertension undergo surgery or medication depending on the cause after completion of standard diagnostic procedures.
Patients with primary hypertension receive medication.
Other Names:
|
patients with PH
patients with primary hypertension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The control rate of blood pressure
Time Frame: 12 months
|
The investigators will compare the proportion of patients with blood pressure below 140/90 mmHg after different treatments.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of carotid imima-media thickness
Time Frame: 12 months
|
Carotid ultrasound will be used to observe the changes of carotid intima-media thickness after different treatments.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gu Yunjuan, M.D/Ph.D, Affiliated Hospital of Nantong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Estimated)
January 31, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
November 25, 2021
First Submitted That Met QC Criteria
November 25, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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