Primary AldosteronismNCT07700888
A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile
An observational study of Primary Aldosteronism and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective observational study evaluates a simplified biochemical screening strategy to differentiate Glucocorticoid-Remediable Aldosteronism (GRA) from Aldosterone-Producing Adenoma (APA). The approach combines a 1-mg overnight dexamethasone suppression test (ODST) with LC-MS/MS steroid profiling. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Primary Aldosteronism, Primary Aldosteronism Due to Aldosterone Producing Adenoma
- What is being tested?
- 1 mg overnight dexamethasone inhibition test
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Aug 2025
- How long will I take part?
- 4 Weeks
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of 31 patients diagnosed with Primary Aldosteronism (PA), including 8 cases of genetically confirmed Glucocorticoid-Remediable Aldosteronism (GRA) and 23 cases of Aldosterone-Producing Adenoma (APA).
Who may be able to join
- Patients diagnosed with Primary Aldosteronism (PA) according to clinical biochemical screening standards.
- GRA Group: Genetically confirmed presence of the $CYP11B1/CYP11B2$ chimeric gene.
- APA group：The patient was diagnosed with PA and the adrenal imaging showed a typical adrenal adenoma on one side. The AVS or Ga68-Pentixafor PET/CT indicated that the adrenal gland on the adenoma side had a dominant secretion of aldosterone. And any of the following conditions was met: (1) The postoperative pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+). (2) After unilateral adrenal resection, the biochemical results of the patient were completely relieved, meeting the surgical outcome criteria for PA.
Who cannot join
- Exclude patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe cardiac and renal insufficiency (eGFR < 30 mL/min/1.73m²), or those who are unable to cooperate to complete the trial process for various reasons.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study evaluates a simplified biochemical screening strategy to differentiate Glucocorticoid-Remediable Aldosteronism (GRA) from Aldosterone-Producing Adenoma (APA). The approach combines a 1-mg overnight dexamethasone suppression test (ODST) with LC-MS/MS steroid profiling. We aim to establish diagnostic cut-off points for aldosterone and hybrid steroid (18-oxoF, 18-OHF) suppression rates as an efficient screening tool prior to genetic testing.
Read the detailed description
Background:
GRA is a rare form of primary aldosteronism where aldosterone secretion is regulated by ACTH. This study evaluates if a 1-mg ODST can effectively suppress aldosterone and hybrid steroids in GRA patients compared to the autonomous secretion observed in APA.Methods:
- Participants: Patients with genetically confirmed GRA or clinically/pathologically confirmed APA are enrolled.
- Procedure: Patients undergo a 1-mg ODST (1 mg dexamethasone at midnight). Blood samples are collected at 08:00 AM at baseline and post-suppression.
- Analysis: 11 steroids, including ALD, 18-oxoF, and 18-OHF, are measured via LC-MS/MS.
- Evaluation: Diagnostic performance is assessed using ROC curves and negative predictive value (NPV) based on a 1% GRA prevalence.Perspective:
This initial phase establishes the diagnostic parameters, which will be further validated in a larger cohort to optimize the screening workflow for primary aldosteronism.
- Being tested
- 1 mg overnight dexamethasone inhibition test
- Keywords
- 1 mg overnight dexamethasone inhibition test, screening
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg overnight dexamethasone inhibition testDiagnostic test
After the patient fasted overnight, venous blood was collected at 08:00 in the morning for baseline steroid profile analysis (including aldosterone, 18-oxycortisol, 18-hydroxy cortisol, etc., a total of 11 types of steroid hormones). At 24:00 that night, the patient took a single oral dose of 1mg dexamethasone tablets. At 08:00 the next morning, venous blood was collected again under the same collection conditions as the baseline to conduct the baseline steroid profile analysis.
| Study group | Role | What they receive |
|---|---|---|
| Aldosterone-producing adenoma | APA group (control group): Patients diagnosed with PA and whose adrenal imaging indicated the presence of a typical adrenal adenoma on one side, with AVS or Ga68-Pentixafor PET/CT suggesting that the adenoma side had a dominant secretion of aldosterone, and meeting any of the following criteria: (1) Post-surgical pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+); (2) Patients who underwent unilateral adrenal resection achieved complete biochemical remission and met the surgical outcome criteria for PA.
Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal and cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who could not cooperate to complete the trial process for any reason were excluded. Receives: Diagnostic Test: 1 mg overnight dexamethasone inhibition test | |
| Familial hyperaldosteronism type 1 | GRA group (case group): Patients who met the biochemical diagnostic criteria for primary aldosteronism, had a clear history of early-onset hypertension or hypertension in their families, and whose CYP11B1/CYP11B2 chimeric gene was confirmed by genetic testing. Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal or cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who cannot cooperate to complete the trial process for various reasons are excluded. Receives: Diagnostic Test: 1 mg overnight dexamethasone inhibition test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST
Measured: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)
Secondary outcomes (2)
Absolute concentration of Plasma Aldosterone (PAC) post-1mg ODST
Measured: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)
Absolute concentration and percent suppression of 11 steroids (including 18-oxoF and 18-OHF).
Measured: Post-1mg ODST (approximately2 weeks after dexamethasone administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Mar 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
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 Union Medical College 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700888
- Sponsor's protocol ID
- pumch-06086-09
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel and Efficient Biochemical Screening Strategy for Glucocorticoid-Remediable Aldosteronism: Combined 1-mg Overnight Dexamethasone Suppression Test and Steroid Profile
- ClinicalTrials.gov ID
- NCT07700888
- Acronym / sponsor ID
- pumch-06086-09
- Keywords
- 1 mg overnight dexamethasone inhibition test, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 Jul 2026 (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 prospective observational study evaluates a simplified biochemical screening strategy to differentiate Glucocorticoid-Remediable Aldosteronism (GRA) from Aldosterone-Producing Adenoma (APA). The approach combines a 1-mg overnight dexamethasone suppression test (ODST) with LC-MS/MS steroid profiling. We aim to establish diagnostic cut-off points for aldosterone and hybrid steroid (18-oxoF, 18-OHF) suppression rates as an efficient screening tool prior to genetic testing.
Detailed description
Background:
GRA is a rare form of primary aldosteronism where aldosterone secretion is regulated by ACTH. This study evaluates if a 1-mg ODST can effectively suppress aldosterone and hybrid steroids in GRA patients compared to the autonomous secretion observed in APA.Methods:
- Participants: Patients with genetically confirmed GRA or clinically/pathologically confirmed APA are enrolled.
- Procedure: Patients undergo a 1-mg ODST (1 mg dexamethasone at midnight). Blood samples are collected at 08:00 AM at baseline and post-suppression.
- Analysis: 11 steroids, including ALD, 18-oxoF, and 18-OHF, are measured via LC-MS/MS.
- Evaluation: Diagnostic performance is assessed using ROC curves and negative predictive value (NPV) based on a 1% GRA prevalence.Perspective:
This initial phase establishes the diagnostic parameters, which will be further validated in a larger cohort to optimize the screening workflow for primary aldosteronism.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aldosterone-producing adenoma | – | Diagnostic Test: 1 mg overnight dexamethasone inhibition testAPA group (control group): Patients diagnosed with PA and whose adrenal imaging indicated the presence of a typical adrenal adenoma on one side, with AVS or Ga68-Pentixafor PET/CT suggesting that the adenoma side had a dominant secretion of aldosterone, and meeting any of the following criteria: (1) Post-surgical pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+); (2) Patients who underwent unilateral adrenal resection achieved complete biochemical remission and met the surgical outcome criteria for PA. Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal and cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who could not cooperate to complete the trial process for any reason were excluded. |
| Familial hyperaldosteronism type 1 | – | Diagnostic Test: 1 mg overnight dexamethasone inhibition testGRA group (case group): Patients who met the biochemical diagnostic criteria for primary aldosteronism, had a clear history of early-onset hypertension or hypertension in their families, and whose CYP11B1/CYP11B2 chimeric gene was confirmed by genetic testing. Exclusion criteria: Patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe renal or cardiac dysfunction (eGFR < 30 mL/min/1.73m²), or those who cannot cooperate to complete the trial process for various reasons are excluded. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of 31 patients diagnosed with Primary Aldosteronism (PA), including 8 cases of genetically confirmed Glucocorticoid-Remediable Aldosteronism (GRA) and 23 cases of Aldosterone-Producing Adenoma (APA).
Key inclusion criteria (3 listed)
- Patients diagnosed with Primary Aldosteronism (PA) according to clinical biochemical screening standards.
- GRA Group: Genetically confirmed presence of the $CYP11B1/CYP11B2$ chimeric gene.
- APA group：The patient was diagnosed with PA and the adrenal imaging showed a typical adrenal adenoma on one side. The AVS or Ga68-Pentixafor PET/CT indicated that the adrenal gland on the adenoma side had a dominant secretion of aldosterone. And any of the following conditions was met: (1) The postoperative pathology clearly confirmed an adrenal cortical adenoma, with immunohistochemistry showing aldosterone synthase CYP11B2 (+). (2) After unilateral adrenal resection, the biochemical results of the patient were completely relieved, meeting the surgical outcome criteria for PA.
Key exclusion criteria (1 listed)
- Exclude patients with secondary hypertension caused by other reasons (such as Cushing's syndrome, pheochromocytoma), severe cardiac and renal insufficiency (eGFR < 30 mL/min/1.73m²), or those who are unable to cooperate to complete the trial process for various reasons.
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 |
|---|---|---|
| 1 mg overnight dexamethasone inhibition testAfter the patient fasted overnight, venous blood was collected at 08:00 in the morning for baseline steroid profile analysis (including aldosterone, 18-oxycortisol, 18-hydroxy cortisol, etc., a total of 11 types of steroid hormones). At 24:00 that night, the patient took a single oral dose of 1mg dexamethasone tablets. At 08:00 the next morning, venous blood was collected again under the same collection conditions as the baseline to conduct the baseline steroid profile analysis. | Diagnostic test | Aldosterone-producing adenoma, Familial hyperaldosteronism type 1 |
Primary outcome
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST
Time frame: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)
2 secondary outcomes
Absolute concentration of Plasma Aldosterone (PAC) post-1mg ODST
Time frame: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)
Absolute concentration and percent suppression of 11 steroids (including 18-oxoF and 18-OHF).
Time frame: Post-1mg ODST (approximately2 weeks after dexamethasone administration)
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 14 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Primary Aldosteronism Due to Aldosterone Producing Adenoma, run by Peking Union Medical College 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 1 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 14 Jul 2026. 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?
Percent suppression of Plasma Aldosterone Concentration (PAC) after 1-mg ODST (time frame: Post-1mg ODST (approximately 2 weeks after dexamethasone administration)). 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 14 Jul 2026.