Primary AldosteronismODPANCT02755519
Optimizing Diagnosis Of Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
To optimize the confirmatory tests for primary aldosteronism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Oct 2016
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group 1: Who was diagnosed with hypertension according to JNC standard and was considered with the possibility of primary aldosteronism. Group 2: Control Groups, one group for those without hypertension or with primary hypertension; the other group for those with adrenal diseases except for primary aldosteronism.
Who may be able to join
- With hypertension;
- With adrenal diseases
Who cannot join
- Pregnant or during lactation period;
- Under 18 yr;
- BMI ≤ 19 or ≥ 35
- With Cancer medical history
- Been through cardiovascular diseases in the past 3 months;
- Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
To optimize the confirmatory tests for primary aldosteronism.
Read the detailed description
In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, confirmatory test, hypertension
- Medical subject headings
- Hyperaldosteronism, 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 |
|---|---|---|
| Primary Aldosteronism | 1. Those with hypertension, and with or without hypoglycemia; 2. Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1 | |
| Non-Primary Aldosteronism | 1. Those with Primary Hypertension; 2. Those with adrenal diseases except for Primary Aldosteronism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUC) for Salt loading test
Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated.
Measured: 1 week
AUC for captopril challenge test
Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
Measured: 1 week
AUC for fludrocortisone suppression test
Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
Measured: 1 week
Secondary outcomes (1)
Incidence of cardiovascular diseases in Primary Aldosteronism
Follow-up for the risk of cardiovascular diseases, chronic kidney disease and stroke
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionOct 2016
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Qifu Li, M.D., PhD., Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755519
- Sponsor's protocol ID
- ODPA 2016
- Acronym
- ODPA
- Status last verified
- Nov 2016
- First submitted
- 8 Apr 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rossi GP, Belfiore A, Bernini G, Desideri G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Montemurro D, Palumbo G, Rizzoni D, Rossi E, Semplicini A, Agabiti-Rosei E, Pessina AC, Mantero F; PAPY Study Investigators. Prospective evaluation of the saline infusion test for excluding primary aldosteronism due to aldosterone-producing adenoma. J Hypertens. 2007 Jul;25(7):1433-42. doi: 10.1097/HJH.0b013e328126856e.
PubMed 17563566Ahmed AH, Cowley D, Wolley M, Gordon RD, Xu S, Taylor PJ, Stowasser M. Seated saline suppression testing for the diagnosis of primary aldosteronism: a preliminary study. J Clin Endocrinol Metab. 2014 Aug;99(8):2745-53. doi: 10.1210/jc.2014-1153. Epub 2014 Apr 24.
PubMed 24762111Li Y, Liu Y, Li J, Wang X, Yu Y. Sodium Infusion Test for Diagnosis of Primary Aldosteronism in Chinese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):89-95. doi: 10.1210/jc.2015-2840. Epub 2015 Nov 13.
PubMed 26565948Nanba K, Tamanaha T, Nakao K, Kawashima ST, Usui T, Tagami T, Okuno H, Shimatsu A, Suzuki T, Naruse M. Confirmatory testing in primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1688-94. doi: 10.1210/jc.2011-2504. Epub 2012 Mar 14.
PubMed 22419718Schirpenbach C, Seiler L, Maser-Gluth C, Rudiger F, Nickel C, Beuschlein F, Reincke M. Confirmatory testing in normokalaemic primary aldosteronism: the value of the saline infusion test and urinary aldosterone metabolites. Eur J Endocrinol. 2006 Jun;154(6):865-73. doi: 10.1530/eje.1.02164.
PubMed 16728547Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. doi: 10.1161/01.hyp.37.6.1440.
PubMed 11408392
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Detection and Confirmation, Subtype Classification of Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT02755519
- Acronym / sponsor ID
- ODPA / ODPA 2016
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, confirmatory test, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Apr 2016 (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.
To optimize the confirmatory tests for primary aldosteronism.
Detailed description
In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Aldosteronism | – | –1. Those with hypertension, and with or without hypoglycemia; 2. Those with PAC/PRC≥42.95 pg·mL-1/µIU·mL-1 |
| Non-Primary Aldosteronism | – | –1. Those with Primary Hypertension; 2. Those with adrenal diseases except for Primary Aldosteronism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1: Who was diagnosed with hypertension according to JNC standard and was considered with the possibility of primary aldosteronism. Group 2: Control Groups, one group for those without hypertension or with primary hypertension; the other group for those with adrenal diseases except for primary aldosteronism.
Key inclusion criteria (2 listed)
- With hypertension;
- With adrenal diseases
Key exclusion criteria (6 listed)
- Pregnant or during lactation period;
- Under 18 yr;
- BMI ≤ 19 or ≥ 35
- With Cancer medical history
- Been through cardiovascular diseases in the past 3 months;
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
Area under the receiver operating characteristic curve (AUC) for Salt loading test
Time frame: 1 week
Salt loading test will be performed and compared to golden standard such as adrenal venous sampling (AVS) and biopsy results. The area under the curve (AUC) will be calculated.
AUC for captopril challenge test
Time frame: 1 week
Captopril challenge test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
AUC for fludrocortisone suppression test
Time frame: 1 week
Fludrocortisone suppression test will be performed and compared to golden standard such as AVS and biopsy results. AUC will be calculated.
1 secondary outcome
Incidence of cardiovascular diseases in Primary Aldosteronism
Time frame: 3 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 11 Nov 2016.
- Background: PubMed 17563566Rossi GP, Belfiore A, Bernini G, Desideri G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Montemurro D, Palumbo G, Rizzoni D, Rossi E, Semplicini A, Agabiti-Rosei E, Pessina AC, Mantero F; PAPY Study Investigators. Prospective evaluation of the saline infusion test for excluding primary aldosteronism due to aldosterone-producing adenoma. J Hypertens. 2007 Jul;25(7):1433-42. doi: 10.1097/HJH.0b013e328126856e.
- Background: PubMed 24762111Ahmed AH, Cowley D, Wolley M, Gordon RD, Xu S, Taylor PJ, Stowasser M. Seated saline suppression testing for the diagnosis of primary aldosteronism: a preliminary study. J Clin Endocrinol Metab. 2014 Aug;99(8):2745-53. doi: 10.1210/jc.2014-1153. Epub 2014 Apr 24.
- Background: PubMed 26565948Li Y, Liu Y, Li J, Wang X, Yu Y. Sodium Infusion Test for Diagnosis of Primary Aldosteronism in Chinese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):89-95. doi: 10.1210/jc.2015-2840. Epub 2015 Nov 13.
- Background: PubMed 22419718Nanba K, Tamanaha T, Nakao K, Kawashima ST, Usui T, Tagami T, Okuno H, Shimatsu A, Suzuki T, Naruse M. Confirmatory testing in primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1688-94. doi: 10.1210/jc.2011-2504. Epub 2012 Mar 14.
- Background: PubMed 16728547Schirpenbach C, Seiler L, Maser-Gluth C, Rudiger F, Nickel C, Beuschlein F, Reincke M. Confirmatory testing in normokalaemic primary aldosteronism: the value of the saline infusion test and urinary aldosterone metabolites. Eur J Endocrinol. 2006 Jun;154(6):865-73. doi: 10.1530/eje.1.02164.
- Background: PubMed 11408392Agharazii M, Douville P, Grose JH, Lebel M. Captopril suppression versus salt loading in confirming primary aldosteronism. Hypertension. 2001 Jun;37(6):1440-3. doi: 10.1161/01.hyp.37.6.1440.
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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.
Qifu Li, M.D., PhD. principal investigator
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 6 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 11 Nov 2016. 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?
Area under the receiver operating characteristic curve (AUC) for Salt loading test (time frame: 1 week). 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 NCT02755519, 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 11 Nov 2016.