Primary Aldosteronism Due to Aldosterone Producing AdenomaNCT05927961
Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia
An observational study of Primary Aldosteronism Due to Aldosterone Producing Adenoma and Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Third Military Medical University at 1 site in China.
Trial summary
Primary aldosteronism (PA) is a common cause of secondary hypertension, which is characterized by excessive aldosterone production by the adrenal gland. Excessive aldosterone can significantly increase the risk of cardiovascular disease and stroke. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- What is being tested?
- histopathology
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to 25 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We'd like to collect the samples of adrenal from primary aldosterone patients due to aldosterone-producing adenoma and unilateral hyperplasia from August 2023 to May 2024.
Who may be able to join
- According to the 2020 guidelines for primary aldosteronism, patients with positive primary aldosteronism confirmed test;
- Patients with predominant unilateral aldosterone secretion at AVS; adrenal CT suggesting unilateral adrenal adenoma (> 0.8cm diameter) and no abnormalities in contralateral adrenal morphology.
- Patients who agreed to do the adrenalectomy.
Who cannot join
- adrenal CT suggests abnormal bilateral adrenal morphology or unilateral nodules.
- glucocorticoids can treat aldosteronism (GRA) and familial aldosteronism.
- other secondary hypertension: renal parenchymal hypertension, renal artery stenosis, Cushing syndrome, adrenal myeloid hyperplasia, aortic narrowing, obstructive sleep apnea hypoventilation syndrome.
- any other unsuitable condition for surgery.
- Patients who refused to perform adrenalectomy.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of the Third Military Medical University
Chongqing
Zhencheng Yan, MD, +86023729582, zhenchengyan@sina.com
About this study
Official title: Spatial Proteomics Profiles of Adrenal Adenoma/Hyperplasia Leading to Primary Aldosterone
Primary aldosteronism (PA) is a common cause of secondary hypertension, which is characterized by excessive aldosterone production by the adrenal gland. Excessive aldosterone can significantly increase the risk of cardiovascular disease and stroke. Patients with aldosterone-producing adenoma (APA) or unilateral hyperplasia (UAH) can be cured by unilateral adrenalectomy. The adrenal cortex is the outer part of the adrenal gland and is subdivided into three layers- the zona glomerulosa, the zona fasciculata, and the zona reticularis. And the outermost layer is the zona glomerulosa, and it's full of cells that make the hormone aldosterone. Although it has been investigated that the main cause of APA or UAH is the mutations of different calcium ion channels, including KCNJ5, CACNA1D, CLCN2 et al, it is still unknown whether there are any other changes of other proteins in different layers. Therefore, the investigators designed the study to characterize the proteomics profiles of adrenal adenoma/hyperplasia leading to primary aldosterone and identify biomarkers for early identification of PA by using spatial proteomics. The samples from adrenal adenoma or hyperplasia will be collected and analyzed by spatial proteomics in Hangzhou Jingjie Biotechnology Co., Ltd. The differentially expressed proteins in different layers will be screened out between APA and UAH, APA and its adjacent normal tissues, and UAH and its adjacent normal tissues, respectively. And KEGG analysis will be conducted to determine enriched pathway in these differentially expressed protein, respectively.
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- Being tested
- histopathology
- Keywords
- primary aldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histopathologyDiagnostic test
There is a clear boundary between adrenal adenoma and surrounding normal tissue. There is no clear boundary between adrenal hyperplasia and surrounding normal tissues.
| Study group | Role | What they receive |
|---|---|---|
| aldosterone-producing adenoma | Histopathology shows a clear boundary between adrenal adenoma and surrounding normal tissue. Receives: Diagnostic Test: histopathology | |
| unilateral hyperplasia | Histopathology shows no clear boundary between adrenal hyperplasia and surrounding normal tissues. Receives: Diagnostic Test: histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for the biomarkers.
Histological validation of the CYP11B2 positive area in APA and UAH by immunohistochemical staining (IHC). Some specimens will be characterized more deeply with advanced spatial proteomics technologies to identify the biomarkers.
Measured: After APA/UAH resection/biopsy, usually within 6 months
Secondary outcomes (2)
Incorporate biomarkers into the accurate and early diagnosis of PA.
Verifying the relationship between biomarkers and clinical presentations, including plasma aldosterone concentrations (PAC), aldosterone to rein ratio (ARR), direct renin concentration (DRC), and serum potassium, etc. Comparing the relationships between biomarkers and risk factors, including osas and family history, etc. Establishing a mathematical model for diagnosing PA through machine learning and studying the pathogenesis of PA through corresponding animal models.
Measured: 12 months
Identifying the relationship between biomarkers and the prognosis of PA.
The alteration of blood pressure and medication status are investigated through 3 months followed up. Verifying the relationship between the biomarkers and the function of APA and UAH, as well as the prognosis of PA.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study startAug 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Aldosteronism Due to Aldosterone Producing AdenomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
- Investigators
- Yan Zhencheng, MD, Principal investigator, The third hospital affiliated to the Third Millitary Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927961
- Sponsor's protocol ID
- SPP of APA/UAH
- Status last verified
- Jun 2023
- First submitted
- 17 Apr 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Proteomics Profiles of Adrenal Adenoma/Hyperplasia Leading to Primary Aldosterone
- ClinicalTrials.gov ID
- NCT05927961
- Acronym / sponsor ID
- SPP of APA/UAH
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- Keywords
- primary aldosteronism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 3 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.
Primary aldosteronism (PA) is a common cause of secondary hypertension, which is characterized by excessive aldosterone production by the adrenal gland. Excessive aldosterone can significantly increase the risk of cardiovascular disease and stroke. Patients with aldosterone-producing adenoma (APA) or unilateral hyperplasia (UAH) can be cured by unilateral adrenalectomy. The adrenal cortex is the outer part of the adrenal gland and is subdivided into three layers- the zona glomerulosa, the zona fasciculata, and the zona reticularis. And the outermost layer is the zona glomerulosa, and it's full of cells that make the hormone aldosterone. Although it has been investigated that the main cause of APA or UAH is the mutations of different calcium ion channels, including KCNJ5, CACNA1D, CLCN2 et al, it is still unknown whether there are any other changes of other proteins in different layers. Therefore, the investigators designed the study to characterize the proteomics profiles of adrenal adenoma/hyperplasia leading to primary aldosterone and identify biomarkers for early identification of PA by using spatial proteomics. The samples from adrenal adenoma or hyperplasia will be collected and analyzed by spatial proteomics in Hangzhou Jingjie Biotechnology Co., Ltd. The differentially expressed proteins in different layers will be screened out between APA and UAH, APA and its adjacent normal tissues, and UAH and its adjacent normal tissues, respectively. And KEGG analysis will be conducted to determine enriched pathway in these differentially expressed protein, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aldosterone-producing adenoma | – | Diagnostic Test: histopathologyHistopathology shows a clear boundary between adrenal adenoma and surrounding normal tissue. |
| unilateral hyperplasia | – | Diagnostic Test: histopathologyHistopathology shows no clear boundary between adrenal hyperplasia and surrounding normal tissues. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We'd like to collect the samples of adrenal from primary aldosterone patients due to aldosterone-producing adenoma and unilateral hyperplasia from August 2023 to May 2024.
Key inclusion criteria (3 listed)
- According to the 2020 guidelines for primary aldosteronism, patients with positive primary aldosteronism confirmed test;
- Patients with predominant unilateral aldosterone secretion at AVS; adrenal CT suggesting unilateral adrenal adenoma (> 0.8cm diameter) and no abnormalities in contralateral adrenal morphology.
- Patients who agreed to do the adrenalectomy.
Key exclusion criteria (5 listed)
- adrenal CT suggests abnormal bilateral adrenal morphology or unilateral nodules.
- glucocorticoids can treat aldosteronism (GRA) and familial aldosteronism.
- other secondary hypertension: renal parenchymal hypertension, renal artery stenosis, Cushing syndrome, adrenal myeloid hyperplasia, aortic narrowing, obstructive sleep apnea hypoventilation syndrome.
- any other unsuitable condition for surgery.
- Patients who refused to perform adrenalectomy.
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 |
|---|---|---|
| histopathologyThere is a clear boundary between adrenal adenoma and surrounding normal tissue. There is no clear boundary between adrenal hyperplasia and surrounding normal tissues. | Diagnostic test | aldosterone-producing adenoma, unilateral hyperplasia |
Primary outcome
Screening for the biomarkers.
Time frame: After APA/UAH resection/biopsy, usually within 6 months
Histological validation of the CYP11B2 positive area in APA and UAH by immunohistochemical staining (IHC). Some specimens will be characterized more deeply with advanced spatial proteomics technologies to identify the biomarkers.
2 secondary outcomes
Incorporate biomarkers into the accurate and early diagnosis of PA.
Time frame: 12 months
Identifying the relationship between biomarkers and the prognosis of PA.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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.
Yan Zhencheng, MD principal investigator
The third hospital affiliated to the Third Millitary Medical University
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 Due to Aldosterone Producing Adenoma and Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Third Military 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 3 inclusion and 5 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 3 Jul 2023. 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 Yan Zhencheng, MD (86-13983656682 ext. 86-02368757882, zhenchengyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening for the biomarkers. (time frame: After APA/UAH resection/biopsy, usually within 6 months). 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 3 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.