Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy (PA-SELECT)

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism; Suprarenalectomy; Super Selective Adrenal Artery Embolization
• Intervention / Treatment: Procedure: Superselective adrenal artery embolization or adrenalectomy

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 Type: Interventional
• Enrollment (Estimated): 570
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Xie, PhD; Phone Number: +869914366892; Email: xiangxie999@sina.com
• Study Contact Backup: Name: Changjiang Deng; Phone Number: +869914366892; Email: 1187229853@qq.com

Study Locations

• China
  • Xinjiang
    • Ürümqi, Xinjiang, China, 630000
      • Recruiting
      • The first affiliated hospital of Xinjiang medical university
      • Contact: Xiang xie; Phone Number: +869914366892; Email: xiangxie999@sina.com
      • Contact: Changjiang Deng; Phone Number: +869914366892; Email: 1187229853@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Study Population

Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superselective adrenal artery embolization group; Superselective adrenal artery embolization for primary aldosteronism	Procedure: Superselective adrenal artery embolization or adrenalectomy; Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.; Other Names: Adrenalectomy
Active Comparator: Adrenalectomy group; Adrenalectomy for primary aldosteronism	Procedure: Superselective adrenal artery embolization or adrenalectomy; Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.; Other Names: Adrenalectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months post intervention
Complete clinical cure of PA	Complete clinical cure of PA, defined as normotension without antihypertensive medication	6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the number of antihypertensive medications	Difference in the change of the number of antihypertensive medications	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)	Reported throughout the study period. Approximately 2 years
Readmission rate	Readmission rate, defined as readmission for primary aldosteronism	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)	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)	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)	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)	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)	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	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	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	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)	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)	1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Changes in ambulatory blood pressure and baseline blood pressure	24-hour ambulatory blood pressure and office systolic and diastolic pressure	1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Collaborators and Investigators

• Sponsor: Xinjiang Medical University
• Collaborators: First Affiliated Hospital of Xinjiang Medical University
• Investigators: Study Chair: Ying-Ying Zheng, PhD, 1st affiliatted hospital of Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 20240613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No