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The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.
As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super selective adrenal artery embolization | SAAE for primary aldosteronism | ||
| adrenectomy | Surgery to remove part of the adrenal gland | ||
| Standard drug therapy | Drug treatment of primary aldosteronism |
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| 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:
| 6 months post intervention |
| Complete clinical cure of PA | Complete clinical cure of PA, defined as normotension without antihypertensive medication These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as <140/80 in the office, <135/85 at home or daytime ambulatory monitoring and <130/80 for 24h ambulatory blood pressure monitoring (24hABPM). | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of the number of antihypertensive medications |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Xie | Contact | +869914366892 | xiangxie999@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 630000 | China |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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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 |