Primary AldosteronismPMNCT05959863
Primary Aldosteronism LC-MS/MS-specific Cutoffs
An observational study of Primary Aldosteronism, run by Chongqing Medical University at 2 sites in China.
Trial summary
Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Captopril Challenge Test
- Type of treatment
- Pill or oral medicine
- How many people
- 396 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2023to 31 Jul 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study intends to include patients taking hypertension medication at each center between June 2023 and July 2024 with subjects signing written informed consent.
Who may be able to join
- Age is between 18-75 years old.
- Hypertension patients with high risk factors for PA (meeting one of the following criteria): a.Persistent hypertension (> 150 / 100mmHg); b. Refractory hypertension (combined with 3 antihypertensive drugs and one used as a diuretic,Blood pressure is still greater than 140 / 90 mmHg or four antihypertensive drugs are needed to control blood pressure of less than 140 / 90 mmHg); c.Hypertension with adrenal accidental tumor; d.Hypertension is associated with hypokalaemia;
- Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: β receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics.
Who cannot join
- Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study;
- Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.);
- Combined with severe renal insufficiency eGFR <30 ml/min / 1.73 m2, Or patients with liver insufficiency OR liver failure (Alanine aminotransferase and / or aspartate aminotransferase increased 2.5 times above the upper limit of normal);
- Clinical assessment of a dressing change risk, Including: Heart failure (NYHA stage grade II or above), any one or more of the stroke, myocardial infarction, and unstable angina pectoris diagnosed within three months;
- Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids;
- incurable malignancy;
- Other reasons make it difficult to change or stop the drug to complete the diagnosis.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qifu Li
Chongqing, Chongqing Municipality, 400016
Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
About this study
Official title: LC-MS/MS-specific Cutoffs for Screening and Confirmatory Testing of Primary Aldosteronism: A Multi-center Study
Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.
Read the detailed description
Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.
- Conditions
- Primary Aldosteronism
- Being tested
- Captopril Challenge Test
- Keywords
- Diagnostic, Multicenter study
- Medical subject headings
- Hyperaldosteronism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril Challenge TestDiagnostic test
Patients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril.
| Study group | Role | What they receive |
|---|---|---|
| Primary Aldosteronism Group | Patients diagnosed with primary aldosteronism Receives: Diagnostic Test: Captopril Challenge Test | |
| Essential Hypertension Group | Patients diagnosed with essential hypertension Receives: Diagnostic Test: Captopril Challenge Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism.
Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.Plasma aldosterone concentration and plasma renin activity will be combined and reported as an aldosterone-to-renin ratio.
Measured: At baseline without medication interfering.
Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism.
Measure the plasma aldosterone concentration by LC-MS/MS.
Measured: 2 hours after the captopril challenge test without medication interfering.
Secondary outcomes (2)
Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.
Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.
Plasma aldosterone concentration and plasma renin activity will be combined and reported as an aldosterone-to-renin ratio.
Measured: At baseline with medication interfering.
compare the different criteria of Captopril Challenge Test for the diagnosis of primary aldosteronism.
plasma aldosterone concentration were measured using automated chemiluminescence immunoassays.
Measured: 2 hours after the captopril challenge test without medication interfering.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Qifu Li, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959863
- Sponsor's protocol ID
- PM-China 2023
- Acronym
- PM
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulatero P, di Cella SM, Monticone S, Schiavone D, Manzo M, Mengozzi G, Rabbia F, Terzolo M, Gomez-Sanchez EP, Gomez-Sanchez CE, Veglio F. 18-hydroxycorticosterone, 18-hydroxycortisol, and 18-oxocortisol in the diagnosis of primary aldosteronism and its subtypes. J Clin Endocrinol Metab. 2012 Mar;97(3):881-9. doi: 10.1210/jc.2011-2384. Epub 2012 Jan 11.
PubMed 22238407Xu 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 32327102Fuss CT, Brohm K, Kurlbaum M, Hannemann A, Kendl S, Fassnacht M, Deutschbein T, Hahner S, Kroiss M. Confirmatory testing of primary aldosteronism with saline infusion test and LC-MS/MS. Eur J Endocrinol. 2021 Jan;184(1):167-178. doi: 10.1530/EJE-20-0073.
PubMed 33112272Young 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 30255616Olsen MH, Angell SY, Asma S, Boutouyrie P, Burger D, Chirinos JA, Damasceno A, Delles C, Gimenez-Roqueplo AP, Hering D, Lopez-Jaramillo P, Martinez F, Perkovic V, Rietzschel ER, Schillaci G, Schutte AE, Scuteri A, Sharman JE, Wachtell K, Wang JG. A call to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet. 2016 Nov 26;388(10060):2665-2712. doi: 10.1016/S0140-6736(16)31134-5. Epub 2016 Sep 23. No abstract available.
PubMed 27671667Rehan M, Raizman JE, Cavalier E, Don-Wauchope AC, Holmes DT. Laboratory challenges in primary aldosteronism screening and diagnosis. Clin Biochem. 2015 Apr;48(6):377-87. doi: 10.1016/j.clinbiochem.2015.01.003. Epub 2015 Jan 22.
PubMed 25619896
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LC-MS/MS-specific Cutoffs for Screening and Confirmatory Testing of Primary Aldosteronism: A Multi-center Study
- ClinicalTrials.gov ID
- NCT05959863
- Acronym / sponsor ID
- PM / PM-China 2023
- Conditions
- Primary Aldosteronism
- Keywords
- Diagnostic, Multicenter study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Tianjin Medical University General Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Jul 2023 (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.
Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.
Detailed description
Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Aldosteronism Group | – | Diagnostic Test: Captopril Challenge TestPatients diagnosed with primary aldosteronism |
| Essential Hypertension Group | – | Diagnostic Test: Captopril Challenge TestPatients diagnosed with essential hypertension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study intends to include patients taking hypertension medication at each center between June 2023 and July 2024 with subjects signing written informed consent.
Key inclusion criteria (3 listed)
- Age is between 18-75 years old.
- Hypertension patients with high risk factors for PA (meeting one of the following criteria): a.Persistent hypertension (> 150 / 100mmHg); b. Refractory hypertension (combined with 3 antihypertensive drugs and one used as a diuretic,Blood pressure is still greater than 140 / 90 mmHg or four antihypertensive drugs are needed to control blood pressure of less than 140 / 90 mmHg); c.Hypertension with adrenal accidental tumor; d.Hypertension is associated with hypokalaemia;
- Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: β receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics.
Key exclusion criteria (7 listed)
- Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study;
- Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.);
- Combined with severe renal insufficiency eGFR <30 ml/min / 1.73 m2, Or patients with liver insufficiency OR liver failure (Alanine aminotransferase and / or aspartate aminotransferase increased 2.5 times above the upper limit of normal);
- Clinical assessment of a dressing change risk, Including: Heart failure (NYHA stage grade II or above), any one or more of the stroke, myocardial infarction, and unstable angina pectoris diagnosed within three months;
- Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids;
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 |
|---|---|---|
| Captopril Challenge TestPatients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril. | Diagnostic test | Essential Hypertension Group, Primary Aldosteronism Group |
Primary outcome
Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism.
Time frame: At baseline without medication interfering.
Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.Plasma aldosterone concentration and plasma renin activity will be combined and reported as an aldosterone-to-renin ratio.
Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism.
Time frame: 2 hours after the captopril challenge test without medication interfering.
Measure the plasma aldosterone concentration by LC-MS/MS.
2 secondary outcomes
Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism.
Time frame: At baseline with medication interfering.
compare the different criteria of Captopril Challenge Test for the diagnosis of primary aldosteronism.
Time frame: 2 hours after the captopril challenge test without medication interfering.
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 16 Dec 2024.
- Background: PubMed 22238407Mulatero P, di Cella SM, Monticone S, Schiavone D, Manzo M, Mengozzi G, Rabbia F, Terzolo M, Gomez-Sanchez EP, Gomez-Sanchez CE, Veglio F. 18-hydroxycorticosterone, 18-hydroxycortisol, and 18-oxocortisol in the diagnosis of primary aldosteronism and its subtypes. J Clin Endocrinol Metab. 2012 Mar;97(3):881-9. doi: 10.1210/jc.2011-2384. Epub 2012 Jan 11.
- Results publication: 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.
- Results publication: PubMed 33112272Fuss CT, Brohm K, Kurlbaum M, Hannemann A, Kendl S, Fassnacht M, Deutschbein T, Hahner S, Kroiss M. Confirmatory testing of primary aldosteronism with saline infusion test and LC-MS/MS. Eur J Endocrinol. 2021 Jan;184(1):167-178. doi: 10.1530/EJE-20-0073.
- 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 27671667Olsen MH, Angell SY, Asma S, Boutouyrie P, Burger D, Chirinos JA, Damasceno A, Delles C, Gimenez-Roqueplo AP, Hering D, Lopez-Jaramillo P, Martinez F, Perkovic V, Rietzschel ER, Schillaci G, Schutte AE, Scuteri A, Sharman JE, Wachtell K, Wang JG. A call to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet. 2016 Nov 26;388(10060):2665-2712. doi: 10.1016/S0140-6736(16)31134-5. Epub 2016 Sep 23. No abstract available.
- Results publication: PubMed 25619896Rehan M, Raizman JE, Cavalier E, Don-Wauchope AC, Holmes DT. Laboratory challenges in primary aldosteronism screening and diagnosis. Clin Biochem. 2015 Apr;48(6):377-87. doi: 10.1016/j.clinbiochem.2015.01.003. Epub 2015 Jan 22.
- 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 study chair
First Affiliated Hospital of Chongqing Medical University
2 sites 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 2 sites 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 3 inclusion and 7 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism. (time frame: At baseline without medication interfering.). The study lists 2 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 NCT05959863, 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 16 Dec 2024.