Primary AldosteronismNCT06571084
New Screening and Diagnostic Cut-off Points of PA Patients
An observational study of Primary Aldosteronism, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 770 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2024to 31 Dec 2025
- 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: Patients aged 18-75 years old and highly suspected primary aldosteronism will be included. Patients will be excluded if who is secondary hypertension other than PA, chronic cardiac dysfunction (NYHA III-IV), medium and several kidney dysfunction (Ccr<30ml/min), with history of liver cirrhosis, oncosis and recent use of steroids or oral contraceptives, pregnant or lactating.
Who may be able to join
- 18-75y;
- persistent hypertension (BP >150/100 mm Hg), or drug-resistant hypertension;
- newly diagnosed hypertension;
- hypertension and spontaneous or diuretic-induced hypokalemia;
- hypertension with adrenal incidentaloma;
- hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (<40 years);
- status as a hypertensive first-degree relative of patients with PA;
- patients with hypertension and obstructive sleep apnea.
Who cannot join
- age <18; BMI ≤ 18.0kg/m2 or ≥ 35.0 kg/m2;
- a diagnosis of secondary hypertension other than PA;
- chronic cardiac dysfunction (NYHA III-IV);
- medium and several kidney dysfunction (Ccr<30ml/min);
- liver cirrhosis;
- terminal malignant tumor;
- recent use of steroids or oral contraceptives;
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Jun Cai contact
China1 site, 1 recruiting
- Recruiting
Kai-juan Wang
Beijing, 100037
Kai-juan Wang, +86 10 88322021, wkaijuan@126.com
About this study
Official title: Establishment and Clinical Application Evaluation of Screening and Diagnostic Cut-off Points With Aldosterone and Renin for Primary Aldosteronism Patients
This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.
Read the detailed description
Primary aldosteronism (PA) is the most common causes of secondary hypertension. The diagnostic workup for PA is composed of multiple steps and requires measurement of both plasma aldosterone and renin. In terms of assay of aldosterone, most of currently available chemiluminescence assays are based on competitive methods. What is actually detected is the sum of aldosterone and its metabolite aldosterone 3C glucuronide, which causes the value to be about 50%~100% higher than the actual value. This study aims to establish a new ARR (aldosterone/renin ratio) cutoff point for PA screening and a new cutoff point for PA diagnosis, using a recently developed two-site sandwich chemiluminescence method (Snibe, China) for aldosterone and renin assay.
Hypertensive patients referred to hospitals for screening of PA will be included. All the participants proceed to seated saline infusion test (SIT) and captopril challenge test (CCT) for confirmation. Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer (DiaSorin, Italy) and MAGLUMI X8 (Snibe, China), as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform. According to the experience of Fuwai Hospital, the following diagnosis criteria are proposed: Based on the results of currently used (DiaSorin, Italy), aldosterone > 8.5ng/dL and renin < 15μIU/mL after sitting saline infusion conform PA, and aldosterone ≤ 8.5ng/dL excludes PA.
The total number of cases to be enrolled in this study is planned to be 770, including at least 77 positive subjects and at least 406 negative subjects. By drawing the ROC curve, the point corresponding to the maximum value of the Youden index will be selected as the cutoff value, and the corresponding sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, etc. will be calculated.
- Conditions
- Primary Aldosteronism
- Keywords
- aldosterone, renin, Primary Aldosteronism, cut-off value, diagnosis
- Medical subject headings
- Hyperaldosteronism, Disease
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 |
|---|---|---|
| suspected PA | Patients with a high risk for PA who were willing to participate in the study were recruited. The inclusion criteria1 were as follows: persistent hypertension (BP >150/100 mm Hg), or drug-resistant hypertension; newly diagnosed hypertension; hypertension and spontaneous or diuretic-induced hypokalemia; hypertension with adrenal incidentaloma; hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (<40 years); or status as a hypertensive first-degree relative of patients with PA; patients with hypertension and obstructive sleep apnea. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary confirmation positive for primary aldosteronism
Aldosterone ≥ 85pg/ml after sitting saline test
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start4 Jan 2024
- Primary completionOct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- 770 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Beijing Anzhen Hospital, First Affiliated Hospital of Chongqing Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Wuhan Asia Heart Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Cai, Study chair, Chinese Academy of Medical Sciences, Fuwai HospitalZhou Zhou, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571084
- Sponsor's protocol ID
- 2023-2260
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Application Evaluation of Screening and Diagnostic Cut-off Points With Aldosterone and Renin for Primary Aldosteronism Patients
- ClinicalTrials.gov ID
- NCT06571084
- Acronym / sponsor ID
- 2023-2260
- Conditions
- Primary Aldosteronism
- Keywords
- aldosterone, renin, Primary Aldosteronism, cut-off value, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Beijing Anzhen Hospital, First Affiliated Hospital of Chongqing Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Wuhan Asia Heart Hospital
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
This study aims to establish the screening and diagnostic cut-off points for primary aldosteronism patients by a novel small molecule "sandwich method" aldosterone and renin chemiluminescent immunoassay.
Detailed description
Primary aldosteronism (PA) is the most common causes of secondary hypertension. The diagnostic workup for PA is composed of multiple steps and requires measurement of both plasma aldosterone and renin. In terms of assay of aldosterone, most of currently available chemiluminescence assays are based on competitive methods. What is actually detected is the sum of aldosterone and its metabolite aldosterone 3C glucuronide, which causes the value to be about 50%~100% higher than the actual value. This study aims to establish a new ARR (aldosterone/renin ratio) cutoff point for PA screening and a new cutoff point for PA diagnosis, using a recently developed two-site sandwich chemiluminescence method (Snibe, China) for aldosterone and renin assay.
Hypertensive patients referred to hospitals for screening of PA will be included. All the participants proceed to seated saline infusion test (SIT) and captopril challenge test (CCT) for confirmation. Aldosterone and renin will be measured using chemiluminescent immunoassay on the Liaison analyzer (DiaSorin, Italy) and MAGLUMI X8 (Snibe, China), as well as liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform. According to the experience of Fuwai Hospital, the following diagnosis criteria are proposed: Based on the results of currently used (DiaSorin, Italy), aldosterone > 8.5ng/dL and renin < 15μIU/mL after sitting saline infusion conform PA, and aldosterone ≤ 8.5ng/dL excludes PA.
The total number of cases to be enrolled in this study is planned to be 770, including at least 77 positive subjects and at least 406 negative subjects. By drawing the ROC curve, the point corresponding to the maximum value of the Youden index will be selected as the cutoff value, and the corresponding sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, etc. will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected PA | – | –Patients with a high risk for PA who were willing to participate in the study were recruited. The inclusion criteria1 were as follows: persistent hypertension (BP >150/100 mm Hg), or drug-resistant hypertension; newly diagnosed hypertension; hypertension and spontaneous or diuretic-induced hypokalemia; hypertension with adrenal incidentaloma; hypertension and a family history of early-onset hypertension or cerebrovascular accident at a young age (<40 years); or status as a hypertensive first-degree relative of patients with PA; patients with hypertension and obstructive sleep apnea. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years old and highly suspected primary aldosteronism will be included. Patients will be excluded if who is secondary hypertension other than PA, chronic cardiac dysfunction (NYHA III-IV), medium and several kidney dysfunction (Ccr<30ml/min), with history of liver cirrhosis, oncosis and recent use of steroids or oral contraceptives, pregnant or lactating.
Key inclusion criteria (8 listed)
- 18-75y;
- persistent hypertension (BP >150/100 mm Hg), or drug-resistant hypertension;
- newly diagnosed hypertension;
- hypertension and spontaneous or diuretic-induced hypokalemia;
- hypertension with adrenal incidentaloma;
Key exclusion criteria (8 listed)
- age <18; BMI ≤ 18.0kg/m2 or ≥ 35.0 kg/m2;
- a diagnosis of secondary hypertension other than PA;
- chronic cardiac dysfunction (NYHA III-IV);
- medium and several kidney dysfunction (Ccr<30ml/min);
- liver cirrhosis;
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
Preliminary confirmation positive for primary aldosteronism
Time frame: 1 month
Aldosterone ≥ 85pg/ml after sitting saline test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Jun Cai contact
Jun Cai study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
Zhou Zhou study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
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 China National Center for Cardiovascular Diseases 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Cai (caijun7879@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary confirmation positive for primary aldosteronism (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.