Hyperaldosteronism; PrimaryPA-ChinaNCT03155139
Primary Aldosteronism In Hypertensive Patients in China
An observational study of Hyperaldosteronism; Primary and Hypertension Secondary, run by Qifu Li at 1 site in China.
Trial summary
To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperaldosteronism; Primary, Hypertension Secondary
- What is being tested?
- Aldosterone/renin ratio (ARR) testing and Confirmatory tests
- Type of treatment
- Injection or infusion
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2017to 30 Nov 2018
- 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: Sampling Design: hypertensive patients will be continuously sampled for case detection in each center. PASS 11.0 Software-Confidence Intervals for One Proportion was used to calculate the sample size. A sample size of 2928 produces a two-sided 95% confidence interval with a width equal to 0.02 when the sample proportion(prevalence of PA) is 0.080. Accounting for the 20% withdraw rate in the process of case detection, the final sample size should be 3635 (about 4000 cases).
Who may be able to join
- Newly diagnosed hypertension(with a course less than six months);
- Drug negative, or voluntary to discontinue/change the anti-hypertensive medications;
- Aged between 18-80 year, gender is not limited;
- Voluntary to sign on the informed consent.
Who cannot join
- patients with severe cardiac, hepatic or renal dysfunction;
- suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension.
Read the detailed description
This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai, Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. This study will be completed in two years.
- Being tested
- Aldosterone/renin ratio (ARR) testing, Confirmatory tests
- Keywords
- prevalence, primary aldosteronism, hypertension, nationwide
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldosterone/renin ratio (ARR) testingDiagnostic test
Plasma aldosterone concentration tests, Direct renin concentration tests
Confirmatory testsDiagnostic test
Captopril challenge test, Saline infusion test
| Study group | Role | What they receive |
|---|---|---|
| Patients without primary aldosteronism (PA) | PA case detection or confirmatory tests was negative. Receives: Diagnostic Test: Aldosterone/renin ratio (ARR) testing | |
| Patients with primary aldosteronism (PA) | PA case detection and confirmatory tests were positive. Receives: Diagnostic Test: Aldosterone/renin ratio (ARR) testing; Diagnostic Test: Confirmatory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with newly diagnosed hypertension
To calculate the prevalence of PA in Chinese patients with hypertension
Measured: 2 years
Number of subjects with confirmed primary aldosteronism (PA)
To calculate the prevalence of PA in Chinese patients with hypertension
Measured: 2 years
Prevalence of PA
Prevalence of PA= Number of PA / Number of subjects with hypertension
Measured: 2 years
Secondary outcomes (5)
Age
Characteristics of PA in Chinese patients with hypertension
Measured: 2 years
Blood pressure
Characteristics of PA in Chinese patients with hypertension
Measured: 2 years
Family history of hypertension
Characteristics of PA in Chinese patients with hypertension
Measured: 2 years
Fasting blood glucose
Characteristics of PA in Chinese patients with hypertension
Measured: 2 years
Cardiovascular events
Characteristics of PA in Chinese patients with hypertension
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start3 Jun 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hyperaldosteronism; PrimaryStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qifu Li
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Responsible party
- Sponsor-investigator, Qifu Li, Chongqing Medical University
- Investigators
- Jun Cai, phD, Principal investigator, Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155139
- Sponsor's protocol ID
- PA-China 2017
- Acronym
- PA-China
- Status last verified
- Oct 2020
- First submitted
- 28 Apr 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Goswami R, Yang S, Li Q. Aldosterone/direct renin concentration ratio as a screening test for primary aldosteronism: A meta-analysis. J Renin Angiotensin Aldosterone Syst. 2016 Aug 17;17(3):1470320316657450. doi: 10.1177/1470320316657450. Print 2016 Jul.
PubMed 27534428Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
PubMed 26934393Kayser SC, Dekkers T, Groenewoud HJ, van der Wilt GJ, Carel Bakx J, van der Wel MC, Hermus AR, Lenders JW, Deinum J. Study Heterogeneity and Estimation of Prevalence of Primary Aldosteronism: A Systematic Review and Meta-Regression Analysis. J Clin Endocrinol Metab. 2016 Jul;101(7):2826-35. doi: 10.1210/jc.2016-1472. Epub 2016 May 12.
PubMed 27172433Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.
PubMed 32327102
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Aldosteronism In Hypertensive Patients in China
- ClinicalTrials.gov ID
- NCT03155139
- Acronym / sponsor ID
- PA-China / PA-China 2017
- Keywords
- prevalence, primary aldosteronism, hypertension, nationwide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Qifu LiUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 May 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.
To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension.
Detailed description
This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai, Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. This study will be completed in two years.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without primary aldosteronism (PA) | – | Diagnostic Test: Aldosterone/renin ratio (ARR) testingPA case detection or confirmatory tests was negative. |
| Patients with primary aldosteronism (PA) | – | Diagnostic Test: Aldosterone/renin ratio (ARR) testing, Diagnostic Test: Confirmatory testsPA case detection and confirmatory tests were positive. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sampling Design: hypertensive patients will be continuously sampled for case detection in each center. PASS 11.0 Software-Confidence Intervals for One Proportion was used to calculate the sample size. A sample size of 2928 produces a two-sided 95% confidence interval with a width equal to 0.02 when the sample proportion(prevalence of PA) is 0.080. Accounting for the 20% withdraw rate in the process of case detection, the final sample size should be 3635 (about 4000 cases).
Key inclusion criteria (4 listed)
- Newly diagnosed hypertension(with a course less than six months);
- Drug negative, or voluntary to discontinue/change the anti-hypertensive medications;
- Aged between 18-80 year, gender is not limited;
- Voluntary to sign on the informed consent.
Key exclusion criteria (2 listed)
- patients with severe cardiac, hepatic or renal dysfunction;
- suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.
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 |
|---|---|---|
| Aldosterone/renin ratio (ARR) testingPlasma aldosterone concentration tests, Direct renin concentration tests | Diagnostic test | Patients with primary aldosteronism (PA), Patients without primary aldosteronism (PA) |
| Confirmatory testsCaptopril challenge test, Saline infusion test | Diagnostic test | Patients with primary aldosteronism (PA) |
Primary outcome
Number of subjects with newly diagnosed hypertension
Time frame: 2 years
To calculate the prevalence of PA in Chinese patients with hypertension
Number of subjects with confirmed primary aldosteronism (PA)
Time frame: 2 years
To calculate the prevalence of PA in Chinese patients with hypertension
Prevalence of PA
Time frame: 2 years
Prevalence of PA= Number of PA / Number of subjects with hypertension
5 secondary outcomes
Age
Time frame: 2 years
Blood pressure
Time frame: 2 years
Family history of hypertension
Time frame: 2 years
Fasting blood glucose
Time frame: 2 years
Cardiovascular events
Time frame: 2 years
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 23 Oct 2020.
- Results publication: PubMed 27534428Li X, Goswami R, Yang S, Li Q. Aldosterone/direct renin concentration ratio as a screening test for primary aldosteronism: A meta-analysis. J Renin Angiotensin Aldosterone Syst. 2016 Aug 17;17(3):1470320316657450. doi: 10.1177/1470320316657450. Print 2016 Jul.
- Results publication: PubMed 26934393Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Results publication: PubMed 27172433Kayser SC, Dekkers T, Groenewoud HJ, van der Wilt GJ, Carel Bakx J, van der Wel MC, Hermus AR, Lenders JW, Deinum J. Study Heterogeneity and Estimation of Prevalence of Primary Aldosteronism: A Systematic Review and Meta-Regression Analysis. J Clin Endocrinol Metab. 2016 Jul;101(7):2826-35. doi: 10.1210/jc.2016-1472. Epub 2016 May 12.
- Derived from this study: PubMed 32327102Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.
- Individual participant dataSharing planned: No
Related trials for Hyperaldosteronism; Primary
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
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.
Jun Cai, phD principal investigator
Hypertension Center, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease of China
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 Hyperaldosteronism; Primary and Hypertension Secondary, run by Qifu Li 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 2 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 23 Oct 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?
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.
What does the primary outcome measure?
Number of subjects with newly diagnosed hypertension (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155139, which also lists 4 linked publications.
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 23 Oct 2020.