Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superselective adrenal artery embolization group | Experimental | Superselective adrenal artery embolization for primary aldosteronism |
|
| Adrenalectomy group | Active Comparator | Adrenalectomy for primary aldosteronism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superselective adrenal artery embolization or adrenalectomy | Procedure | Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy. |
|
| 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: Normalisation of serum potassium, and Normalisation of ARR, or Elevated ARR and i). Baseline PAC <190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria) | 6 months post intervention |
| Complete clinical cure of PA | Complete clinical cure of PA, defined as normotension without antihypertensive medication | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Xie, PhD | Contact | +869914366892 | xiangxie999@sina.com | |
| Changjiang Deng | Contact | +869914366892 | 1187229853@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying-Ying Zheng, PhD | 1st affiliatted hospital of Xinjiang Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 630000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000315 | Adrenalectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided