Hypertension, Resistant to Conventional TherapyNCT01459042
Prevalence of Primary Aldosteronism in Patients With Resistant Hypertension in China
An observational study of Hypertension, Resistant to Conventional Therapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Recent studies indicate that primary aldosteronism (PA) is a much more common cause of hypertension than had been demonstrated historically. In patients with resistant hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Oct 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resistant hypertension from different provinces of China
Who may be able to join
- patients with resistant hypertension
- age 18-65 years
Who cannot join
- known cause of hypertension
- heart failure
- renal dysfunction
- Stroke, transient ischaemic attack or myocardial infarction in the past 6 months
- cirrhosis
- pregnancy
- undertreatment of glucocorticoid
Trial locations and contacts
1 site in 1 country.
China1 site
Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Prevalence of Primary Aldosteronism and Status of Renin-Angiotensin System in Resistant Hypertension:An Observational Study in China
Recent studies indicate that primary aldosteronism (PA) is a much more common cause of hypertension than had been demonstrated historically. In patients with resistant hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has been no such data in China, the investigators are conducting a PA study in different province of China to evaluate the prevalence of PA in patients with resistant hypertension.
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
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 |
|---|---|---|
| primary aldosteronism | Not described | |
| essential hypertension | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
- Investigators
- Weiqing Wang, MD, PhD, Principal investigator, Endocrinology Department of Ruijin Hospital affiliated Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459042
- Sponsor's protocol ID
- 19830409
- Status last verified
- Oct 2011
- First submitted
- 21 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Primary Aldosteronism and Status of Renin-Angiotensin System in Resistant Hypertension:An Observational Study in China
- ClinicalTrials.gov ID
- NCT01459042
- Acronym / sponsor ID
- 19830409
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- First posted
- 25 Oct 2011 (estimated)
- 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.
Recent studies indicate that primary aldosteronism (PA) is a much more common cause of hypertension than had been demonstrated historically. In patients with resistant hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has been no such data in China, the investigators are conducting a PA study in different province of China to evaluate the prevalence of PA in patients with resistant hypertension.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary aldosteronism | – | – |
| essential hypertension | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resistant hypertension from different provinces of China
Key inclusion criteria (2 listed)
- patients with resistant hypertension
- age 18-65 years
Key exclusion criteria (7 listed)
- known cause of hypertension
- heart failure
- renal dysfunction
- Stroke, transient ischaemic attack or myocardial infarction in the past 6 months
- cirrhosis
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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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.
Weiqing Wang, MD, PhD principal investigator
Endocrinology Department of Ruijin Hospital affiliated Shanghai Jiao Tong University School of Medicine
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, Resistant to Conventional Therapy, run by Shanghai Jiao Tong University School of Medicine 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 2 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: finished, as of the sponsor's last update on 25 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Oct 2011.