Primary AldosteronismNCT07111351
Multi-omics Studies of Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Peking University First Hospital at 1 site in China.
Trial summary
Primary aldosteronism is a prevalent yet underdiagnosed cause of secondary hypertension, contributing to significant cardiovascular morbidity and renal dysfunction. Despite affecting up to 20% of hypertensive patients, PA is frequently missed because it lacks distinctive clinical features and often presents with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Without intervention
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 31 May 2029
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of participants recruited at Peking University First Hospital from May 2025 to May 2029. Eligible participants must meet all inclusion criteria: (1) diagnosis of primary aldosteronism, primary hypertension, or being age- and sex-matched healthy controls; (2) aged 18-80 years with complete medical records; and (3) voluntary participation with informed consent provision. Exclusion criteria include: (1) history of adrenal region chemotherapy/radiotherapy; (2) positive HIV/hepatitis B/C serology or prior diagnosis; (3) presence of malignancies or autoimmune disorders; and (4) withdrawal during the trial period. The study plans to enroll 400 patients.
Who may be able to join
- Diagnosed with primary aldosteronism , primary hypertension , or age- and sex-matched healthy controls;
- Aged 18-80 years with complete medical records;
- Willing to participate voluntarily and provide informed consent.
Who cannot join
- History of chemotherapy or radiotherapy in the adrenal region ;
- Positive serological or nucleic acid test results for HIV, hepatitis B, or hepatitis C , or a prior confirmed diagnosis;
- Individuals with malignancies or autoimmune disorders ;
- Study withdrawal during the trial period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zheng Zhang, +8613901371490, doczhz@aliyun.com
About this study
Primary aldosteronism is a prevalent yet underdiagnosed cause of secondary hypertension, contributing to significant cardiovascular morbidity and renal dysfunction. Despite affecting up to 20% of hypertensive patients, PA is frequently missed because it lacks distinctive clinical features and often presents with nonspecific symptoms like resistant hypertension or subtle electrolyte imbalances. The diagnostic pathway involves a stepwise approach: initial screening via the aldosterone-to-renin ratio, confirmatory testing (e.g., saline suppression or captopril challenge), and subtype differentiation using adrenal venous sampling to distinguish unilateral adenoma from bilateral hyperplasia. This complexity, combined with clinician unfamiliarity and variable access to specialized centers, perpetuates underdiagnosis. Early identification and tailored treatment are paramount in improving outcomes for patients with primary aldosteronism.
In this study, we will conduct a comprehensive multi-omics analysis on three sample types: 1) blood and urine samples from patients with primary aldosteronism, primary hypertension, and healthy controls; and 2) adrenal tissue samples from patients undergoing adrenalectomy for aldosterone-producing adenomas. We aim to systematically identify differentially expressed biomarkers that could serve as potential early diagnostic markers for primary aldosteronism. The findings may provide new insights into disease pathogenesis and contribute to improving early detection and personalized treatment strategies for this condition.
- Conditions
- Primary Aldosteronism
- Being tested
- Without intervention
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without interventionOther
Without intervention
| Study group | Role | What they receive |
|---|---|---|
| Aldosterone-producing adenoma | Not described Receives: Other: Without intervention | |
| Idiopathic hyperaldosteronism | Not described Receives: Other: Without intervention | |
| Primary Hpertension | Not described Receives: Other: Without intervention | |
| Health control | Not described Receives: Other: Without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-omics data and analysis results
Collect various types of biological samples and utilize advanced proteomics and metabolomics technologies to obtain comprehensive omics data. Based on this, combine machine learning algorithms to deeply mine multi-omics data and clinical information, aiming to screen novel biomarkers for the prediction, classification, and diagnosis of primary aldosteronism, and construct a high-precision prediction model.
Measured: May 2025 to May 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion31 May 2029 (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 Peking University First HospitalThe 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
- 400 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111351
- Sponsor's protocol ID
- 2025R0135
- Status last verified
- May 2025
- First submitted
- 1 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and practical considerations. The data contains sensitive personal health information, and sharing it could compromise participant confidentiality and privacy. Additionally, the study's institutional policies prioritize data security, limiting external access to protect against potential misuse or breaches. Ensuring compliance with ethical guidelines and institutional review board requirements further necessitates restricted data availability. While transparency in research is valued, these safeguards are essential to maintaining participant trust and adhering to data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Studies of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07111351
- Acronym / sponsor ID
- 2025R0135
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 8 Aug 2025 (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.
Primary aldosteronism is a prevalent yet underdiagnosed cause of secondary hypertension, contributing to significant cardiovascular morbidity and renal dysfunction. Despite affecting up to 20% of hypertensive patients, PA is frequently missed because it lacks distinctive clinical features and often presents with nonspecific symptoms like resistant hypertension or subtle electrolyte imbalances. The diagnostic pathway involves a stepwise approach: initial screening via the aldosterone-to-renin ratio, confirmatory testing (e.g., saline suppression or captopril challenge), and subtype differentiation using adrenal venous sampling to distinguish unilateral adenoma from bilateral hyperplasia. This complexity, combined with clinician unfamiliarity and variable access to specialized centers, perpetuates underdiagnosis. Early identification and tailored treatment are paramount in improving outcomes for patients with primary aldosteronism.
In this study, we will conduct a comprehensive multi-omics analysis on three sample types: 1) blood and urine samples from patients with primary aldosteronism, primary hypertension, and healthy controls; and 2) adrenal tissue samples from patients undergoing adrenalectomy for aldosterone-producing adenomas. We aim to systematically identify differentially expressed biomarkers that could serve as potential early diagnostic markers for primary aldosteronism. The findings may provide new insights into disease pathogenesis and contribute to improving early detection and personalized treatment strategies for this condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aldosterone-producing adenoma | – | Other: Without intervention |
| Idiopathic hyperaldosteronism | – | Other: Without intervention |
| Primary Hpertension | – | Other: Without intervention |
| Health control | – | Other: Without intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of participants recruited at Peking University First Hospital from May 2025 to May 2029. Eligible participants must meet all inclusion criteria: (1) diagnosis of primary aldosteronism, primary hypertension, or being age- and sex-matched healthy controls; (2) aged 18-80 years with complete medical records; and (3) voluntary participation with informed consent provision. Exclusion criteria include: (1) history of adrenal region chemotherapy/radiotherapy; (2) positive HIV/hepatitis B/C serology or prior diagnosis; (3) presence of malignancies or autoimmune disorders; and (4) withdrawal during the trial period. The study plans to enroll 400 patients.
Key inclusion criteria (3 listed)
- Diagnosed with primary aldosteronism , primary hypertension , or age- and sex-matched healthy controls;
- Aged 18-80 years with complete medical records;
- Willing to participate voluntarily and provide informed consent.
Key exclusion criteria (4 listed)
- History of chemotherapy or radiotherapy in the adrenal region ;
- Positive serological or nucleic acid test results for HIV, hepatitis B, or hepatitis C , or a prior confirmed diagnosis;
- Individuals with malignancies or autoimmune disorders ;
- Study withdrawal during the trial period
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 |
|---|---|---|
| Without interventionWithout intervention | Other | Aldosterone-producing adenoma, Health control, Idiopathic hyperaldosteronism, Primary Hpertension |
Primary outcome
Multi-omics data and analysis results
Time frame: May 2025 to May 2029
Collect various types of biological samples and utilize advanced proteomics and metabolomics technologies to obtain comprehensive omics data. Based on this, combine machine learning algorithms to deeply mine multi-omics data and clinical information, aiming to screen novel biomarkers for the prediction, classification, and diagnosis of primary aldosteronism, and construct a high-precision prediction model.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and practical considerations. The data contains sensitive personal health information, and sharing it could compromise participant confidentiality and privacy. Additionally, the study's institutional policies prioritize data security, limiting external access to protect against potential misuse or breaches. Ensuring compliance with ethical guidelines and institutional review board requirements further necessitates restricted data availability. While transparency in research is valued, these safeguards are essential to maintaining participant trust and adhering to data protection regulations.
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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.
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 Peking University First Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wencong Han (+8618863665375, hanwencong163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-omics data and analysis results (time frame: May 2025 to May 2029). 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 9 Dec 2025.