Primary AldosteronismNCT03224312
Chongqing Primary Aldosteronism Study
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: hypertensive patients who completed ARR screening and necessary further tests and Voluntary to be followed up will be included.
Who may be able to join
- hypertensive patients who completed ARR screening and necessary further tests;
- Voluntary to sign 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 et al.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qifu Li
Chongqing, Chongqing Municipality, 400016
Qifu Li, PhD, +86 23 89011552, liqifu@yeah.net
About this study
We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.
Read the detailed description
This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.
- Conditions
- Primary Aldosteronism
- Being tested
- no intervention
- Keywords
- Primary aldosteronism, cardiovascular events, cerebrovascular events
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Primary aldosteronism | screened, confirmed and subtyped according to the guidelines. Receives: Other: no intervention | |
| Essential hypertension | screened for PA and excluded the diagnosis of PA as well as other secondary hypertesion Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients who develop cardiovascular events
compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension
Measured: 1-15 years
Secondary outcomes (7)
estimated glomerular filtration rate (eGFR)
Compare the incidence of hypertensive nephropathy between two groups (based on eGFR)
Measured: 1-15 years
The incidence of new atrial fibrillation
Compare the occurrence of new atrial fibrillation between patients with primary aldosteronism and essential hypertension
Measured: 1-15 years
The incidence of left ventricular hypertrophy
Compare the occurrence of left ventricular hypertrophy between patients with primary aldosteronism and essential hypertension
Measured: 1-15 years
the variation of carotid intima-media thickness
Compare the occurrence of the variation of carotid intima-media thickness between patients with primary aldosteronism and essential hypertension
Measured: 1-15 years
subgroup analysis of cardiovascular events
Compare the cardiovascular and cerebrovascular risk between unilateral PA and idiopathic bilateral adrenal hyperplasia
Measured: 1-15 years
quality of life score
Compare the quality of life between unilateral PA and idiopathic bilateral adrenal hyperplasia by the questionnaire.
Measured: 1-15 years
Cardiovascular risk score
To investigate what kind of cardiovascular risk score can better predict cardiovascular risk of PA
Measured: 1-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Oct 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Qifu Li, phD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224312
- Sponsor's protocol ID
- CONPASS
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2017
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.
PubMed 28576687Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
PubMed 28385310Stowasser M, Gordon RD. Primary Aldosteronism: Changing Definitions and New Concepts of Physiology and Pathophysiology Both Inside and Outside the Kidney. Physiol Rev. 2016 Oct;96(4):1327-84. doi: 10.1152/physrev.00026.2015.
PubMed 27535640He C, Li R, Yang J, Shen H, Wang Y, Chen X, Luo W, Zeng Q, Ma L, Song Y, Cheng Q, Wang Z, Wu FF, Li Q, Yang S, Hu J. Optimizing the aldosterone-to-renin ratio cut-off for screening primary aldosteronism based on cardiovascular risk: a collaborative study. Clin Exp Hypertens. 2024 Dec 31;46(1):2301571. doi: 10.1080/10641963.2023.2301571. Epub 2024 Jan 25.
PubMed 38270079Yang Y, Williams TA, Song Y, Yang S, He W, Wang K, Cheng Q, Ma L, Luo T, Yang J, Reincke M, Burrello J, Li Q, Mulatero P, Hu J. Nomogram-Based Preoperative Score for Predicting Clinical Outcome in Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa634. doi: 10.1210/clinem/dgaa634.
PubMed 32898224Wang K, Hu J, Yang J, Song Y, Fuller PJ, Hashimura H, He W, Feng Z, Cheng Q, Du Z, Wang Z, Ma L, Yang S, Li Q. Development and Validation of Criteria for Sparing Confirmatory Tests in Diagnosing Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa282. doi: 10.1210/clinem/dgaa282.
PubMed 32449927
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chongqing Primary Aldosteronism Study
- ClinicalTrials.gov ID
- NCT03224312
- Acronym / sponsor ID
- CONPASS
- Conditions
- Primary Aldosteronism
- Keywords
- Primary aldosteronism, cardiovascular events, cerebrovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Jul 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.
We intends to conduct a series of original clinical research about PA, and establish a large cohort of PA and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. We will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the PA and target organ damage, risk factors, diagnostic methods and biomarkers.
Detailed description
This study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, PA subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary aldosteronism | – | Other: no interventionscreened, confirmed and subtyped according to the guidelines. |
| Essential hypertension | – | Other: no interventionscreened for PA and excluded the diagnosis of PA as well as other secondary hypertesion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hypertensive patients who completed ARR screening and necessary further tests and Voluntary to be followed up will be included.
Key inclusion criteria (2 listed)
- hypertensive patients who completed ARR screening and necessary further tests;
- Voluntary to sign 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 et al.
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 |
|---|---|---|
| no interventionno intervention | Other | Essential hypertension, Primary aldosteronism |
Primary outcome
numbers of patients who develop cardiovascular events
Time frame: 1-15 years
compare the long-term cardiovascular and cerebrovascular events in patients with primary aldosteronism and essential hypertension
7 secondary outcomes
estimated glomerular filtration rate (eGFR)
Time frame: 1-15 years
The incidence of new atrial fibrillation
Time frame: 1-15 years
The incidence of left ventricular hypertrophy
Time frame: 1-15 years
the variation of carotid intima-media thickness
Time frame: 1-15 years
subgroup analysis of cardiovascular events
Time frame: 1-15 years
quality of life score
Time frame: 1-15 years
Cardiovascular risk score
Time frame: 1-15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 28576687Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.
- Background: PubMed 28385310Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
- Background: PubMed 27535640Stowasser M, Gordon RD. Primary Aldosteronism: Changing Definitions and New Concepts of Physiology and Pathophysiology Both Inside and Outside the Kidney. Physiol Rev. 2016 Oct;96(4):1327-84. doi: 10.1152/physrev.00026.2015.
- Derived from this study: PubMed 38270079He C, Li R, Yang J, Shen H, Wang Y, Chen X, Luo W, Zeng Q, Ma L, Song Y, Cheng Q, Wang Z, Wu FF, Li Q, Yang S, Hu J. Optimizing the aldosterone-to-renin ratio cut-off for screening primary aldosteronism based on cardiovascular risk: a collaborative study. Clin Exp Hypertens. 2024 Dec 31;46(1):2301571. doi: 10.1080/10641963.2023.2301571. Epub 2024 Jan 25.
- Derived from this study: PubMed 32898224Yang Y, Williams TA, Song Y, Yang S, He W, Wang K, Cheng Q, Ma L, Luo T, Yang J, Reincke M, Burrello J, Li Q, Mulatero P, Hu J. Nomogram-Based Preoperative Score for Predicting Clinical Outcome in Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa634. doi: 10.1210/clinem/dgaa634.
- Derived from this study: PubMed 32449927Wang K, Hu J, Yang J, Song Y, Fuller PJ, Hashimura H, He W, Feng Z, Cheng Q, Du Z, Wang Z, Ma L, Yang S, Li Q. Development and Validation of Criteria for Sparing Confirmatory Tests in Diagnosing Primary Aldosteronism. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa282. doi: 10.1210/clinem/dgaa282.
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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.
Qifu Li, phD study chair
First Affiliated Hospital of Chongqing Medical University
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 Primary Aldosteronism, run by Chongqing Medical University 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 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: looking for participants now, as of the sponsor's last update on 6 Sep 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qifu Li, phD (+86 023-89011552, liqifu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of patients who develop cardiovascular events (time frame: 1-15 years). 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 NCT03224312, which also lists 6 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 6 Sep 2023.