Primary AldosteronismNCT03500120
Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
The present study was undertaken prospectively to compare the diagnostic significance of the seated saline suppression testing (SSST) with the captopril challenge testing (CCT) in hypertensive patients with suspected primary aldosteronism (PA) using the fludrocortisone suppression testing (FST) as the reference… 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?
- Seated saline infusion test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2019
- 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: Hospital or clinic patients with hypertension in a single tertiary hospital center.
Who may be able to join
- patients with Joint National Commission stage 2 (>160-179/100-109mm Hg), stage 3 (>180/110 mmHg), or drug-resistant hypertension;
- hypertension and spontaneous or diuretic-induced hypokalemia;
- hypertension with adrenal incidentaloma;
- hypertension and a family history of early-onset hypertension;
- cerebrovascular accident at a young age (<40 years);
- all hypertensive first-degree relatives of patients with PA.
Who cannot join
- heart failure;
- chronic kidney disease with an estimated Glomerular Filtration Rate <30 ml/min/1.73 m2;
- liver cirrhosis;
- terminal malignant tumor;
- current use of steroids or oral contraceptives;
- pregnancy or lactation.
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
The present study was undertaken prospectively to compare the diagnostic significance of the seated saline suppression testing (SSST) with the captopril challenge testing (CCT) in hypertensive patients with suspected primary aldosteronism (PA) using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.
Read the detailed description
The diagnosis of primary aldosteronism (PA) typically requires at least one confirmatory test. Four tests are commonly recommended by the Endocrine Society guideline, namely, oral sodium loading, saline infusion, fludrocortisone administration with oral sodium loading, and captopril challenge testing (CCT). Of these, fludrocortisone suppression testing (FST) has been considered the most reliable, but is cumbersome, difficult to perform, and relatively expensive, requiring hospital admission for several days. Alternative approaches to FST have included saline suppression testing (SST), Which requiring patients staying in the recumbent position for at least 1 h before and during the infusion of 2 L of 0.9% saline IV over 4 h. This approach also has the disadvantages of brings much inconvenience to the patient (such as urination or defecation, etc.). Ashraf H. et al. have reported that seated SST (SSST) is more sensitive than recumbent SST (RSST), especially for posture-responsive PA (95.8% versus 33.3%), however, in this small scale study, only 31 patients was PA and only three patients was tested negative for PA by FST. Specificity of each form of SST was unable to estimate and meaningful receiver operating characteristic (ROC) curve analyses could not be performed. Furthermore, it is lack of study in Chinese people. In addition, the investigators have previously found the CCT was as accurate as the FST and plasma aldosterone concentration (PAC) post-CCT is the best approach to interpret the results of the CCT. The present study was undertaken prospectively to compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.
- Conditions
- Primary Aldosteronism
- Being tested
- Seated saline infusion test
- Keywords
- Saline suppression testing, Seated, Recumbent
- Medical subject headings
- Hyperaldosteronism, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated saline infusion testDiagnostic test
Also called Captopril challenge test, Fludrocortisone suppression test
Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.
Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements.
Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge.
| Study group | Role | What they receive |
|---|---|---|
| Primary Aldosteronism | Aldosterone/renin concentration ratio(ARR)≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST≥6 ng/dl Receives: Diagnostic Test: Seated saline infusion test | |
| non Primary Aldosteronism | 1. ARR≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST<6 ng/dl Receives: Diagnostic Test: Seated saline infusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Seated Saline Suppression Test
compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard
Measured: 2 weeks
Secondary outcomes (1)
The cutoff of SSST for diagnosis of PA
investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- 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
- NCT03500120
- Sponsor's protocol ID
- DASSSTPA 2017
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nishikawa 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 21828936Reznik Y, Amar L, Tabarin A. SFE/SFHTA/AFCE consensus on primary aldosteronism, part 3: Confirmatory testing. Ann Endocrinol (Paris). 2016 Jul;77(3):202-7. doi: 10.1016/j.ando.2016.01.007. Epub 2016 Jun 16.
PubMed 27318644Funder 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 26934393Mulatero P, Dluhy RG, Giacchetti G, Boscaro M, Veglio F, Stewart PM. Diagnosis of primary aldosteronism: from screening to subtype differentiation. Trends Endocrinol Metab. 2005 Apr;16(3):114-9. doi: 10.1016/j.tem.2005.02.007.
PubMed 15808809Mulatero 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 16670162Ahmed 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 24762111
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. 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
- NCT03500120
- Acronym / sponsor ID
- DASSSTPA 2017
- Conditions
- Primary Aldosteronism
- Keywords
- Saline suppression testing, Seated, Recumbent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Apr 2018 (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.
The present study was undertaken prospectively to compare the diagnostic significance of the seated saline suppression testing (SSST) with the captopril challenge testing (CCT) in hypertensive patients with suspected primary aldosteronism (PA) using the fludrocortisone suppression testing (FST) as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.
Detailed description
The diagnosis of primary aldosteronism (PA) typically requires at least one confirmatory test. Four tests are commonly recommended by the Endocrine Society guideline, namely, oral sodium loading, saline infusion, fludrocortisone administration with oral sodium loading, and captopril challenge testing (CCT). Of these, fludrocortisone suppression testing (FST) has been considered the most reliable, but is cumbersome, difficult to perform, and relatively expensive, requiring hospital admission for several days. Alternative approaches to FST have included saline suppression testing (SST), Which requiring patients staying in the recumbent position for at least 1 h before and during the infusion of 2 L of 0.9% saline IV over 4 h. This approach also has the disadvantages of brings much inconvenience to the patient (such as urination or defecation, etc.). Ashraf H. et al. have reported that seated SST (SSST) is more sensitive than recumbent SST (RSST), especially for posture-responsive PA (95.8% versus 33.3%), however, in this small scale study, only 31 patients was PA and only three patients was tested negative for PA by FST. Specificity of each form of SST was unable to estimate and meaningful receiver operating characteristic (ROC) curve analyses could not be performed. Furthermore, it is lack of study in Chinese people. In addition, the investigators have previously found the CCT was as accurate as the FST and plasma aldosterone concentration (PAC) post-CCT is the best approach to interpret the results of the CCT. The present study was undertaken prospectively to compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard, and to investigate the optimal cutoff of SSST for differentiating PA from other forms of hypertension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Aldosteronism | – | Diagnostic Test: Seated saline infusion testAldosterone/renin concentration ratio(ARR)≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST≥6 ng/dl |
| non Primary Aldosteronism | – | Diagnostic Test: Seated saline infusion test1. ARR≥1.0 (ng/dl)/(mIU/l) and 2. PAC post-FST<6 ng/dl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital or clinic patients with hypertension in a single tertiary hospital center.
Key inclusion criteria (6 listed)
- patients with Joint National Commission stage 2 (>160-179/100-109mm Hg), stage 3 (>180/110 mmHg), or drug-resistant hypertension;
- hypertension and spontaneous or diuretic-induced hypokalemia;
- hypertension with adrenal incidentaloma;
- hypertension and a family history of early-onset hypertension;
- cerebrovascular accident at a young age (<40 years);
Key exclusion criteria (6 listed)
- heart failure;
- chronic kidney disease with an estimated Glomerular Filtration Rate <30 ml/min/1.73 m2;
- liver cirrhosis;
- terminal malignant tumor;
- current use of steroids or oral contraceptives;
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 |
|---|---|---|
| Seated saline infusion testAlso: Captopril challenge test, Fludrocortisone suppression testSeated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture. Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements. Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge. | Diagnostic test | Primary Aldosteronism, non Primary Aldosteronism |
Primary outcome
Diagnostic Accuracy of Seated Saline Suppression Test
Time frame: 2 weeks
compare the diagnostic significance of the SSST with the CCT in hypertensive patients with suspected PA using the FST as the reference standard
1 secondary outcome
The cutoff of SSST for diagnosis of PA
Time frame: 2 weeks
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 27 Jan 2021.
- Background: 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.
- Background: PubMed 27318644Reznik Y, Amar L, Tabarin A. SFE/SFHTA/AFCE consensus on primary aldosteronism, part 3: Confirmatory testing. Ann Endocrinol (Paris). 2016 Jul;77(3):202-7. doi: 10.1016/j.ando.2016.01.007. Epub 2016 Jun 16.
- 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 15808809Mulatero P, Dluhy RG, Giacchetti G, Boscaro M, Veglio F, Stewart PM. Diagnosis of primary aldosteronism: from screening to subtype differentiation. Trends Endocrinol Metab. 2005 Apr;16(3):114-9. doi: 10.1016/j.tem.2005.02.007.
- 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 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.
- Individual participant dataSharing planned: No
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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, 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 6 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 27 Jan 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 Seated Saline Suppression Test (time frame: 2 weeks). 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 NCT03500120, 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 27 Jan 2021.