An interventional study of Superselective adrenal artery embolization or adrenalectomy in Primary Aldosteronism, Suprarenalectomy and Super Selective Adrenal Artery Embolization, sponsored by Xinjiang Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Xinjiang Medical University · Not applicable, Interventional, and Treatment
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.
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.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 570 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Xinjiang Medical University is the lead sponsor of 21 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Superselective adrenal artery embolization for primary aldosteronism
Procedure: Superselective adrenal artery embolization or adrenalectomy
Adrenalectomy for primary aldosteronism
Procedure: Superselective adrenal artery embolization or adrenalectomy
Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
Also known as: Adrenalectomy
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)
Time frame: 6 months post intervention
Complete clinical cure of PA
Complete clinical cure of PA, defined as normotension without antihypertensive medication
Time frame: 6 months post intervention
Changes in ambulatory blood pressure and baseline blood pressure
24-hour ambulatory blood pressure and office systolic and diastolic 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
Difference in the 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
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)
Time frame: Reported throughout the study period. Approximately 2 years
Readmission rate
Readmission rate, defined as readmission for primary aldosteronism
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
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
Difference in the change of 24-h urine creatinine (umol/L)
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Plan to share: No
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Xinjiang Medical University