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Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Studies have shown that the prevalence of PA in an unselected hypertensive population ranges from 5% to 11% , while the prevalence in patients with resistant hypertension is approximately 20% . PA is one of the most common causes of secondary hypertension , and its prevalence increases with rising blood pressure levels. Due to the adverse effects of PA on the heart, arterial walls, and kidneys, it contributes to the occurrence of cardiovascular events, with atrial fibrillation being the most common . In summary, PA is characterized by rapid onset, significant symptoms, obscurity, and severe complications, making early diagnosis and targeted treatment essential for prevention.
This study aims to explore a quasi-selected prospective randomized controlled method to compare the clinical efficacy differences between single-catheter and dual-catheter adrenal sampling via the right upper limb approach. The study seeks to clarify the effectiveness and safety of single-catheter sampling from the upper limb, providing a more efficient and cost-effective solution for the subtype diagnosis of patients with Primary Aldosteronism (PA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Catheter Adrenal Vein Sampling | Experimental | Patients in the Intervention group will utilize a multifunctional catheter for bilateral adrenal vein sampling. |
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| Double Catheter Adrenal Vein Sampling | Active Comparator | Patients in this group will utilize two catheters for bilateral adrenal vein sampling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single catheter adrenal vein sampling | Procedure | The clinical invasive procedure involves inserting a single catheter into the right and left adrenal veins to collect blood samples from both adrenal veins. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of left-sided adrenal vein sampling between two groups | Biochemical analysis of puncture-point blood samples: A selection index (SI) ≥ 2, defined as the ratio of adrenal plasma cortisol concentration (PCC) to peripheral PCC, indicates successful unilateral aldosterone venous sampling (AVS). | 7 month(End of Trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of material costs between two groups | 7 month(End of Trial) | |
| Change of average operation time of left-side adrenal vein sampling between two groups | The surgical doctor will record the operation time for adrenal vein sampling from the left adrenal vein and compare change of the average operation time between the two groups at end of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li,MD | Contact | 13372683559 | doublepear@tmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Army Medical University, China | Study Director |
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| Double catheters adrenal vein sampling | Procedure | The clinical invasive procedure involves inserting double catheters into the right and left adrenal veins to collect blood samples from both adrenal veins. |
|
| 7 month(End of Trial) |
| Change of average fluoroscopy time of adrenal vein sampling between two groups | Change of average fluoroscopy time of adrenal vein sampling between two groups at the end of the study. | 7 month(End of Trial) |
| Change of the surgical supplies cost between two groups | Change of the surgical supplies cost between two groups at the end of the study. | 7 month(End of Trial) |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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