Clinical trial NCT06513585: Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy
Official title: The First Affiliated Hospital of Xinjiang Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Aldosteronism
Suprarenalectomy
Super Selective Adrenal Artery Embolization
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2024-07-22
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete biochemical cure of PA
timeFrame: 6 months post intervention
measure: Complete clinical cure of PA
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Changes in ambulatory blood pressure and baseline blood pressure
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of the number of antihypertensive medications
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Adverse events
timeFrame: Reported throughout the study period. Approximately 2 years
measure: Readmission rate
timeFrame: Reported throughout the study period. Approximately 2 years
measure: Change of blood electrolytes (K+, Na +)
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma aldosterone
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma cortisol
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma renin measured
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of liver enzymes
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of kidney function
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of fasting blood glucose
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of lipids profiles
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of 24-h urine microalbumin
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of 24-h 24-h urine creatinine
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: 1st affiliatted hospital of Xinjiang Medical University
name: Ying-Ying Zheng, PhD
role: STUDY_CHAIR
References: