Primary AldosteronismNCT04193137
Comparison of Three Confirmatory Tests in the Diagnosis of Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
To compare the diagnostic value of three confirmatory tests for primary aldosteronism. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Oral sodium loading test,Seated saline infusion test and Captopril challenge test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2019to 30 Jun 2021
- 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: hypertensive patients being suspicious of PA in a single tertiary hospital center
Who may be able to join
- hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
- hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically
Who cannot join
- Pregnancy or lactation;
- Child-bearing women refuse to take effective contraceptive measures;
- History of malignant tumor;
- Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
- NYHA III (New York Heart Association)and above
- Hypohepatia
Show all 9Show fewer
- Chronic kidney disease with an estimated Glomerular Filtration Rate <30ml/min/1.73 m²
- Severe arrhythmia by ECG or severe heart disease by cardiac ultrasound
- Patients who are unwilling to participate in and complete this study and refuses to sign the informed consent form for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism
To compare the diagnostic value of three confirmatory tests for primary aldosteronism.
Read the detailed description
This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test
- Conditions
- Primary Aldosteronism
- Being tested
- Oral sodium loading test,Seated saline infusion test and Captopril challenge test
- Keywords
- primary aldosteronism,, oral sodium loading test, captopril challenge test,, Saline infusion test
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sodium loading test,Seated saline infusion test and Captopril challenge testDiagnostic test
Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.
Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.
Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge.
| Study group | Role | What they receive |
|---|---|---|
| Primary Aldosteronism(PA) | plasma aldosterone /renin ratio (ARR)>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC>200 pg/ml，plasma renin concentration(PRC)<2.5μIU/ml，with hypokalemia Receives: Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test | |
| non Primary Aldosteronism | ARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml Receives: Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
sensitivity, specificity and area under curve (AUC)
Measured: 9 days
Secondary outcomes (1)
the optimal cutoff value of urine aldosterone in oral sodium test
urine aldosterone
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start30 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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
- 200 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, PhD, Study chair, the Chongqing Primary Aldosteronism Study (CONPASS) Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193137
- Sponsor's protocol ID
- OSL-study 2019
- Status last verified
- Jul 2021
- First submitted
- 8 Dec 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funder 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 26934393Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25.
PubMed 30255616Wu S, Yang J, Hu J, Song Y, He W, Yang S, Luo R, Li Q. Confirmatory tests for the diagnosis of primary aldosteronism: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2019 May;90(5):641-648. doi: 10.1111/cen.13943. Epub 2019 Feb 26.
PubMed 30721529Mulatero P, Milan A, Fallo F, Regolisti G, Pizzolo F, Fardella C, Mosso L, Marafetti L, Veglio F, Maccario M. Comparison of confirmatory tests for the diagnosis of primary aldosteronism. J Clin Endocrinol Metab. 2006 Jul;91(7):2618-23. doi: 10.1210/jc.2006-0078. Epub 2006 May 2.
PubMed 16670162Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9.
PubMed 21828936Mulatero P, Monticone S, Burrello J, Veglio F, Williams TA, Funder J. Guidelines for primary aldosteronism: uptake by primary care physicians in Europe. J Hypertens. 2016 Nov;34(11):2253-7. doi: 10.1097/HJH.0000000000001088.
PubMed 27607462
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Saline Infusion Test, Captopril Challenge Test, and Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT04193137
- Acronym / sponsor ID
- OSL-study 2019
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism,, oral sodium loading test, captopril challenge test,, Saline infusion test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Dec 2019 (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 compare the diagnostic value of three confirmatory tests for primary aldosteronism.
Detailed description
This is a prospective study involving 240 hypertensive patients who underwent primary aldosteronism screening. Every patient will undertake four confirmatory tests to compare the diagnostic accuracy of the oral sodium loading test with captopril challenge testing (CCT) and Seated saline infusion test(SSST)using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of oral sodium loading test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Aldosteronism(PA) | – | Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge testplasma aldosterone /renin ratio (ARR)>10 pg/μIU and plasma aldosterone concentration(PAC) post-FST≥60pg/ml；or PAC>200 pg/ml，plasma renin concentration(PRC)<2.5μIU/ml，with hypokalemia |
| non Primary Aldosteronism | – | Diagnostic Test: Oral sodium loading test,Seated saline infusion test and Captopril challenge testARR<10 pg/μIU or ARR>10 pg/μIU and PAC post FST<60pg/ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hypertensive patients being suspicious of PA in a single tertiary hospital center
Key inclusion criteria (2 listed)
- hypertensive patients with ARR≥10(pg/ml)(uIU/ml)
- hypertensive patients with ARR<10(pg/ml)(uIU/ml) but suspicious of PA clinically
Key exclusion criteria (9 listed)
- Pregnancy or lactation;
- Child-bearing women refuse to take effective contraceptive measures;
- History of malignant tumor;
- Patients with cardiovascular and cerebrovascular diseases (eg. myocardial infarction, acute heart failure, stroke), in the past 3 months
- NYHA III (New York Heart Association)and above
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 |
|---|---|---|
| Oral sodium loading test,Seated saline infusion test and Captopril challenge testOral sodium loading test : Patients received 6g oral sodium every day for 3 days. Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge. | Diagnostic test | Primary Aldosteronism(PA), non Primary Aldosteronism |
Primary outcome
Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test
Time frame: 9 days
sensitivity, specificity and area under curve (AUC)
1 secondary outcome
the optimal cutoff value of urine aldosterone in oral sodium test
Time frame: 3 days
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 4 Aug 2021.
- 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 30255616Young WF Jr. Diagnosis and treatment of primary aldosteronism: practical clinical perspectives. J Intern Med. 2019 Feb;285(2):126-148. doi: 10.1111/joim.12831. Epub 2018 Sep 25.
- Results publication: PubMed 30721529Wu S, Yang J, Hu J, Song Y, He W, Yang S, Luo R, Li Q. Confirmatory tests for the diagnosis of primary aldosteronism: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2019 May;90(5):641-648. doi: 10.1111/cen.13943. Epub 2019 Feb 26.
- Results publication: PubMed 16670162Mulatero P, Milan A, Fallo F, Regolisti G, Pizzolo F, Fardella C, Mosso L, Marafetti L, Veglio F, Maccario M. Comparison of confirmatory tests for the diagnosis of primary aldosteronism. J Clin Endocrinol Metab. 2006 Jul;91(7):2618-23. doi: 10.1210/jc.2006-0078. Epub 2006 May 2.
- Results publication: PubMed 21828936Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9.
- Results publication: PubMed 27607462Mulatero P, Monticone S, Burrello J, Veglio F, Williams TA, Funder J. Guidelines for primary aldosteronism: uptake by primary care physicians in Europe. J Hypertens. 2016 Nov;34(11):2253-7. doi: 10.1097/HJH.0000000000001088.
- Individual participant dataSharing planned: No
Related trials for Primary Aldosteronism
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.
Qifu Li, PhD study chair
the Chongqing Primary Aldosteronism Study (CONPASS) Group
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 9 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 4 Aug 2021. 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?
Diagnostic Accuracy of oral sodium loading test, captopril challenge test and saline infusion test (time frame: 9 days). 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 NCT04193137, 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 4 Aug 2021.