Status:
RECRUITING
Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy
Lead Sponsor:
Xinjiang Medical University
Collaborating Sponsors:
First Affiliated Hospital of Xinjiang Medical University
Conditions:
Primary Aldosteronism
Suprarenalectomy
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ne...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT06513585
Start Date
August 1 2024
End Date
December 1 2026
Last Update
April 15 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 630000