Idiopathic HyperaldosteronismNCT07328230
Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism
A study testing Superselective Adrenal Arterial Embolization and Spironolactone in people with Idiopathic Hyperaldosteronism and Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Idiopathic Hyperaldosteronism, Hyperaldosteronism
- What is being tested?
- Superselective Adrenal Arterial Embolization and Spironolactone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2022to 31 Dec 2025
- Phase
- Interventional
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged from 15 to 60 with no limits in sex;
- Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
- Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
- Patients or their legal representatives have to sign written informed consent approved by the ethics committee.
Who cannot join
- Unilateral adrenal hyperplasia;
- Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) <45 ml/min/1.73 m², and/or serum creatinine >176 μmol/L；
- Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
- Severe contrast agent allergy;
- Women who are pregnant or planning to become pregnant;
- Patients with other serious organic diseases cannot tolerate SAAE treatment;
- Other forms of secondary hypertension.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Xiongjing Jiang, MD, 86-010-88322387, jxj103@hotmail.com
Hui Dong, MD
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610500
Peijian Wang, MD, 86-18980718263, wpjmed@aliyun.com
- Recruiting
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yifei Dong, MD，PhD, 0791-87357354, yf_dong66@126.com
About this study
Official title: A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone
Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.
Read the detailed description
Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.
- Conditions
- Idiopathic Hyperaldosteronism, Hyperaldosteronism
- Being tested
- Superselective Adrenal Arterial Embolization, Spironolactone
- Keywords
- Superselective adrenal arterial embolization, Spironolactone, Hyperaldosteronism, Hypertension, Mineralocorticoid receptor antagonists(
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superselective Adrenal Arterial EmbolizationProcedure or surgery
Patients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation.
SpironolactoneDrug
Patients will be treated with spironolactone.
| Study group | Role | What they receive |
|---|---|---|
| Superselective Adrenal Arterial Embolization | Experimental | Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization. Receives: Procedure: Superselective Adrenal Arterial Embolization |
| Spironolactone | Active comparator | Patients in this group will receive oral spironolactone. Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-h mean systolic blood pressure at 6 months compared with baseline.
change of 24-h mean systolic blood pressure at 6 months compared with baseline.
Measured: 6 months after randomization
Secondary outcomes (7)
Change of 24-h mean diastolic blood pressure at 6 months compared with baseline.
change of 24-h mean diastolic blood pressure at 6 months compared with baseline.
Measured: 6 months after randomization
Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline
Change of office blood pressure at 1, 3, 6 months compared with baseline
Measured: 1, 3, 6 months after randomization
change of antihypertensive medication burden at 1, 3, 6 months compared with baseline
change of antihypertensive medication burden at 6 months compared with baseline
Measured: 1, 3, 6 months after randomization
Incidence of clinical events
Incidence of clinical events including: major adverse cardiovascular events(MACE), renal insufficiency, adrenal insufficiency, hyperkalemia, vascular complication, flank/back pain, gynecomastia, breast tenderness, sexual dysfunction,etc.
Measured: 6 months after randomization
Change of Serum potassium at 3, 6 months after randomization, compared with baseline
Change of Serum potassium at 3, 6 months compared with baseline
Measured: 3,6 months after randomization
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline
Measured: 3, 6 months after randomization
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline
Measured: 3, 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Chengdu Medical College
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328230
- Sponsor's protocol ID
- 2022-1714
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.
PubMed 33605538Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.
PubMed 34398686
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone
- ClinicalTrials.gov ID
- NCT07328230
- Acronym / sponsor ID
- 2022-1714
- Conditions
- Idiopathic Hyperaldosteronism, Hyperaldosteronism
- Keywords
- Superselective adrenal arterial embolization, Spironolactone, Hyperaldosteronism, Hypertension, Mineralocorticoid receptor antagonists(
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Chengdu Medical College
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jan 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.
Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.
Detailed description
Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superselective Adrenal Arterial Embolization | Experimental | Procedure: Superselective Adrenal Arterial EmbolizationPatients in the experimental group will undergo percutaneous superselective adrenal arterial embolization. |
| Spironolactone | Active comparator | Drug: SpironolactonePatients in this group will receive oral spironolactone. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged from 15 to 60 with no limits in sex;
- Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
- Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
- Patients or their legal representatives have to sign written informed consent approved by the ethics committee.
Key exclusion criteria (7 listed)
- Unilateral adrenal hyperplasia;
- Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) <45 ml/min/1.73 m², and/or serum creatinine >176 μmol/L；
- Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
- Severe contrast agent allergy;
- Women who are pregnant or planning to become pregnant;
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 |
|---|---|---|
| Superselective Adrenal Arterial EmbolizationPatients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation. | Procedure or surgery | Superselective Adrenal Arterial Embolization |
| SpironolactonePatients will be treated with spironolactone. | Drug | Spironolactone |
Primary outcome
Change of 24-h mean systolic blood pressure at 6 months compared with baseline.
Time frame: 6 months after randomization
change of 24-h mean systolic blood pressure at 6 months compared with baseline.
7 secondary outcomes
Change of 24-h mean diastolic blood pressure at 6 months compared with baseline.
Time frame: 6 months after randomization
Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline
Time frame: 1, 3, 6 months after randomization
change of antihypertensive medication burden at 1, 3, 6 months compared with baseline
Time frame: 1, 3, 6 months after randomization
Incidence of clinical events
Time frame: 6 months after randomization
Change of Serum potassium at 3, 6 months after randomization, compared with baseline
Time frame: 3,6 months after randomization
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline
Time frame: 3, 6 months after randomization
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline
Time frame: 3, 6 months after randomization
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 Jan 2026.
- Results publication: PubMed 33605538Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.
- Results publication: PubMed 34398686Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.
- 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.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superselective Adrenal Arterial Embolization and Spironolactone in people with Idiopathic Hyperaldosteronism and Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites 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 4 inclusion and 7 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Xiongjing Jiang, MD (86-010-88322387, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-h mean systolic blood pressure at 6 months compared with baseline. (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07328230, which also lists 2 linked publications.
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 Jan 2026.