Primary Aldosteronism Clinical Trial
Official title:
The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - (1)Aged 18-75 years, males and females; - (2)Blood pressure = 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day; - (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution; - (4)Contraindications to spironolactone-free administration; - (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization; - (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization. Exclusion Criteria: - (1)Secondary hypertension of other causes; - (2)Pregnant women or those who have a fertility plan in the next year; - (3)Glomerular filtration rate EGFR < 45 ml/min/1.73m^2; - (4)History of severe contrast allergy; - (5)Hyperkalemia; - (6)Patients with other serious organic diseases or life expectancy < 12 months can not tolerate the treatment of super selective adrenal artery embolizatio; - (7)The diameter of adrenal space occupying lesions was more than 2 cm; - (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent; - (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Nanchang University | Nanchang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Nanchang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endothelial function | Brachial artery endothelial function measured by flow-mediated dilation(FMD) | 1 month after SAAE | |
Primary | endothelial function | Brachial artery endothelial function measured by flow-mediated dilation(FMD) | 12 months after SAAE | |
Secondary | PAC | plasma aldosterone concentration | 1 month after SAAE | |
Secondary | PAC | plasma aldosterone concentration | 12 months after SAAE | |
Secondary | PRA | plasma renin activity | 1 month after SAAE | |
Secondary | PRA | plasma renin activity | 12 months after SAAE | |
Secondary | ARR | aldosterone-to-renin ratio | 1 month after SAAE | |
Secondary | ARR | aldosterone-to-renin ratio | 12 months after SAAE | |
Secondary | Serum potassium | Serum potassium | 1 month after SAAE | |
Secondary | Serum potassium | Serum potassium | 12 months after SAAE | |
Secondary | serum creatinine | serum creatinine | 1 month after SAAE | |
Secondary | serum creatinine | serum creatinine | 12 months after SAAE |
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