Primary AldosteronismPA-SELECTNCT06513585
Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy
A study testing Superselective adrenal artery embolization or adrenalectomy in people with Primary Aldosteronism and Suprarenalectomy, run by Xinjiang Medical University at 1 site in China.
Trial summary
The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Aldosteronism, Suprarenalectomy, Super Selective Adrenal Artery Embolization
- What is being tested?
- Superselective adrenal artery embolization or adrenalectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Dec 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
- Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
- Patients and their family members signed informed consent and agreed to participate in the study
Who cannot join
- A history of severe hypersensitivity to contrast media
- Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
- Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2)
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
- Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
- Stroke, myocardial infarction and stent implantation occurred in the past 3 months
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- Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
- Participated in other clinical trials within the past 3 months
- Pregnant, breastfeeding, or planning a pregnancy
- Identify patients with alcohol allergy
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 First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 630000
Xiang xie, +869914366892, xiangxie999@sina.com
Changjiang Deng, +869914366892, 1187229853@qq.com
About this study
Official title: The First Affiliated Hospital of Xinjiang Medical University
The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.
Read the detailed description
Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease, which leads to increased sodium and potassium discharge, increased fluid volume and inhibition of renin-angiotensin-aldosterone system. It is one of the common causes of secondary hypertension as clinical symptoms with hypertension, hypokalemia, hyperaldosterone and low renin. It accounts for 5% to 13% of people with hypertension. In addition to the impact of hypertension itself on the body, the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events, and the risk of stroke, atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension, so early detection and reasonable treatment are crucial. PA can be divided into 6 types according to the etiology, of which the most common is idiopathic aldosteronism (IHA) and aldosteronoma, accounting for 60% and 30% respectively, unilateral adrenal hyperplasia followed, the other subtypes are less common. Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA, while unilateral PA is preferred by surgery and laparoscopic adrenalectomy. However, surgical treatment also has many limitations: First, not all patients with surgical indications have the opportunity to undergo adrenal resection. Surgical treatment is not suitable for patients with difficult laparoscopic operation, such as obesity, serious abdominal adhesion due to previous surgical history, and high-risk surgery, such as cardiovascular and cerebrovascular diseases and emphysema. In addition, adrenal resection may lead to adrenal dysfunction, serious infection, retroperitoneal hematoma and many other adverse reactions. The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved. The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria, and to conduct a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
- Being tested
- Superselective adrenal artery embolization or adrenalectomy
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superselective adrenal artery embolization or adrenalectomyProcedure or surgery
Also called Adrenalectomy
Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
| Study group | Role | What they receive |
|---|---|---|
| Superselective adrenal artery embolization group | Experimental | Superselective adrenal artery embolization for primary aldosteronism Receives: Procedure: Superselective adrenal artery embolization or adrenalectomy |
| Adrenalectomy group | Active comparator | Adrenalectomy for primary aldosteronism Receives: Procedure: Superselective adrenal artery embolization or adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete biochemical cure of PA
Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both:
Normalisation of serum potassium, and Normalisation of ARR, or Elevated ARR and i). Baseline PAC <190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Measured: 6 months post intervention
Complete clinical cure of PA
Complete clinical cure of PA, defined as normotension without antihypertensive medication
Measured: 6 months post intervention
Secondary outcomes (14)
Changes in ambulatory blood pressure and baseline blood pressure
24-hour ambulatory blood pressure and office systolic and diastolic pressure
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of the number of antihypertensive medications
Difference in the change of the number of antihypertensive medications
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Adverse events
Will be directly sought at each study visit through history and physical examination where appropriate Subjects will be encouraged to report between study visits and will have a mechanism to do so Will be classified by system, seriousness, causal relationship and expectedness according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Reported throughout the study period. Approximately 2 years
Readmission rate
Readmission rate, defined as readmission for primary aldosteronism
Measured: Reported throughout the study period. Approximately 2 years
Change of blood electrolytes (K+, Na +)
Difference in the change of blood electrolytes (K+, Na + in mmol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma aldosterone
Difference in the change of plasma aldosterone (pg/mL)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma cortisol
Difference in the change of plasma cortisol (nmol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma renin measured
Difference in the change of plasma renin (pg/ml)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of kidney function
Difference in the change of serum creatinine in umol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of lipids profiles
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h urine microalbumin
Difference in the change of 24-h urine microalbumin (mg/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h 24-h urine creatinine
Difference in the change of 24-h urine creatinine (umol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 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.
- 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
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
- Investigators
- Ying-Ying Zheng, PhD, Study chair, 1st affiliatted hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513585
- Sponsor's protocol ID
- 20240613
- Acronym
- PA-SELECT
- Status last verified
- Apr 2025
- First submitted
- 24 Jun 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Xinjiang Medical University
- ClinicalTrials.gov ID
- NCT06513585
- Acronym / sponsor ID
- PA-SELECT / 20240613
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jul 2024 (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 aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.
Detailed description
Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease, which leads to increased sodium and potassium discharge, increased fluid volume and inhibition of renin-angiotensin-aldosterone system. It is one of the common causes of secondary hypertension as clinical symptoms with hypertension, hypokalemia, hyperaldosterone and low renin. It accounts for 5% to 13% of people with hypertension. In addition to the impact of hypertension itself on the body, the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events, and the risk of stroke, atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension, so early detection and reasonable treatment are crucial. PA can be divided into 6 types according to the etiology, of which the most common is idiopathic aldosteronism (IHA) and aldosteronoma, accounting for 60% and 30% respectively, unilateral adrenal hyperplasia followed, the other subtypes are less common. Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA, while unilateral PA is preferred by surgery and laparoscopic adrenalectomy. However, surgical treatment also has many limitations: First, not all patients with surgical indications have the opportunity to undergo adrenal resection. Surgical treatment is not suitable for patients with difficult laparoscopic operation, such as obesity, serious abdominal adhesion due to previous surgical history, and high-risk surgery, such as cardiovascular and cerebrovascular diseases and emphysema. In addition, adrenal resection may lead to adrenal dysfunction, serious infection, retroperitoneal hematoma and many other adverse reactions. The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved. The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria, and to conduct a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superselective adrenal artery embolization group | Experimental | Procedure: Superselective adrenal artery embolization or adrenalectomySuperselective adrenal artery embolization for primary aldosteronism |
| Adrenalectomy group | Active comparator | Procedure: Superselective adrenal artery embolization or adrenalectomyAdrenalectomy for primary aldosteronism |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60
- Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
- Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
- Patients and their family members signed informed consent and agreed to participate in the study
Key exclusion criteria (10 listed)
- A history of severe hypersensitivity to contrast media
- Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
- Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2)
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
- Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
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 artery embolization or adrenalectomyAlso: AdrenalectomyArm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy. | Procedure or surgery | Adrenalectomy group, Superselective adrenal artery embolization group |
Primary outcome
Complete biochemical cure of PA
Time frame: 6 months post intervention
Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both: Normalisation of serum potassium, and Normalisation of ARR, or Elevated ARR and i). Baseline PAC <190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Complete clinical cure of PA
Time frame: 6 months post intervention
Complete clinical cure of PA, defined as normotension without antihypertensive medication
14 secondary outcomes
Changes in ambulatory blood pressure and baseline blood pressure
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of the number of antihypertensive medications
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Adverse events
Time frame: Reported throughout the study period. Approximately 2 years
Readmission rate
Time frame: Reported throughout the study period. Approximately 2 years
Change of blood electrolytes (K+, Na +)
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma aldosterone
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma cortisol
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma renin measured
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of liver enzymes
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of kidney function
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of fasting blood glucose
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of lipids profiles
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h urine microalbumin
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h 24-h urine creatinine
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
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 Apr 2025.
- 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.
Ying-Ying Zheng, PhD study chair
1st affiliatted hospital of Xinjiang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superselective adrenal artery embolization or adrenalectomy in people with Primary Aldosteronism and Suprarenalectomy, run by Xinjiang 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 4 inclusion and 10 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 Apr 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 Xiang Xie, PhD (+869914366892, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete biochemical cure of PA (time frame: 6 months post intervention). 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 Apr 2025.