Primary AldosteronismNCT05561361
The Effect of SAAE on Vascular Endothelial Function in PA Patients
An observational study of Primary Aldosteronism, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation 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?
- Super selective adrenal artery embolization and Spironolactone
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.
Who may be able to join
- (1)Aged 18-75 years, males and females;
- (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day;
- (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
- (4)Contraindications to spironolactone-free administration;
- (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
- (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.
Who cannot join
- (1)Secondary hypertension of other causes;
- (2)Pregnant women or those who have a fertility plan in the next year;
- (3)Glomerular filtration rate EGFR < 45 ml/min/1.73m^2;
- (4)History of severe contrast allergy;
- (5)Hyperkalemia;
- (6)Patients with other serious organic diseases or life expectancy < 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;
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- (7)The diameter of adrenal space occupying lesions was more than 2 cm;
- (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;
- (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.
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
The Second Affiliated Hospital of Nanchang University
Nanchang
Yifei Dong, doctorate, +8613576007061, yf_dong66@126.com
About this study
Official title: The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation
Read the detailed description
After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.
- Conditions
- Primary Aldosteronism
- Being tested
- Super selective adrenal artery embolization, Spironolactone
- Keywords
- primary aldosteronism, selective adrenal artery embolization, vascular endothelial function
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super selective adrenal artery embolizationProcedure or surgery
Also called SAAE
Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.
SpironolactoneDrug
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.
| Study group | Role | What they receive |
|---|---|---|
| SAAE group | Subjects received super selective adrenal artery embolization treatment Receives: Procedure: Super selective adrenal artery embolization | |
| Spironolactone group | Subjects received spironolactone treatment Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Brachial artery endothelial function measured by flow-mediated dilation(FMD)
Measured: 1 month after SAAE
endothelial function
Brachial artery endothelial function measured by flow-mediated dilation(FMD)
Measured: 12 months after SAAE
Secondary outcomes (10)
PAC
plasma aldosterone concentration
Measured: 1 month after SAAE
PAC
plasma aldosterone concentration
Measured: 12 months after SAAE
PRA
plasma renin activity
Measured: 1 month after SAAE
PRA
plasma renin activity
Measured: 12 months after SAAE
ARR
aldosterone-to-renin ratio
Measured: 1 month after SAAE
ARR
aldosterone-to-renin ratio
Measured: 12 months after SAAE
Serum potassium
Serum potassium
Measured: 1 month after SAAE
Serum potassium
Serum potassium
Measured: 12 months after SAAE
serum creatinine
serum creatinine
Measured: 1 month after SAAE
serum creatinine
serum creatinine
Measured: 12 months after SAAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (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 Second Affiliated Hospital of Nanchang UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yifei Dong, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561361
- Sponsor's protocol ID
- IIT-O-2021-032
- Status last verified
- May 2025
- First submitted
- 27 Sep 2022
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation
- ClinicalTrials.gov ID
- NCT05561361
- Acronym / sponsor ID
- IIT-O-2021-032
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, selective adrenal artery embolization, vascular endothelial function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 2022 (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.
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation
Detailed description
After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAAE group | – | Procedure: Super selective adrenal artery embolizationSubjects received super selective adrenal artery embolization treatment |
| Spironolactone group | – | Drug: SpironolactoneSubjects received spironolactone treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.
Key inclusion criteria (6 listed)
- (1)Aged 18-75 years, males and females;
- (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day;
- (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
- (4)Contraindications to spironolactone-free administration;
- (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
Key exclusion criteria (9 listed)
- (1)Secondary hypertension of other causes;
- (2)Pregnant women or those who have a fertility plan in the next year;
- (3)Glomerular filtration rate EGFR < 45 ml/min/1.73m^2;
- (4)History of severe contrast allergy;
- (5)Hyperkalemia;
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 |
|---|---|---|
| Super selective adrenal artery embolizationAlso: SAAESuperselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure. | Procedure or surgery | SAAE group |
| SpironolactoneAldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism. | Drug | Spironolactone group |
Primary outcome
endothelial function
Time frame: 1 month after SAAE
Brachial artery endothelial function measured by flow-mediated dilation(FMD)
endothelial function
Time frame: 12 months after SAAE
Brachial artery endothelial function measured by flow-mediated dilation(FMD)
10 secondary outcomes
PAC
Time frame: 1 month after SAAE
PAC
Time frame: 12 months after SAAE
PRA
Time frame: 1 month after SAAE
PRA
Time frame: 12 months after SAAE
ARR
Time frame: 1 month after SAAE
ARR
Time frame: 12 months after SAAE
Serum potassium
Time frame: 1 month after SAAE
Serum potassium
Time frame: 12 months after SAAE
serum creatinine
Time frame: 1 month after SAAE
serum creatinine
Time frame: 12 months after SAAE
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 15 Dec 2025.
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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.
Yifei Dong study director
Second Affiliated Hospital of Nanchang 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, run by Second Affiliated Hospital of Nanchang 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 6 inclusion and 9 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 15 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 Yifei Dong, Doctorate (+8613576007061, yf_dong66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function (time frame: 1 month after SAAE). 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?
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 15 Dec 2025.