Not provided
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 |
|---|---|
| Second Affiliated Hospital of Nanchang University | OTHER |
| First Affiliated Hospital of Chengdu Medical College | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.
Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superselective Adrenal Arterial Embolization | Experimental | Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization. |
|
| Spironolactone | Active Comparator | Patients in this group will receive oral spironolactone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superselective Adrenal Arterial Embolization | Procedure | Patients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h mean systolic blood pressure at 6 months compared with baseline. | change of 24-h mean systolic blood pressure at 6 months compared with baseline. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h mean diastolic blood pressure at 6 months compared with baseline. | change of 24-h mean diastolic blood pressure at 6 months compared with baseline. | 6 months after randomization |
| Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiongjing Jiang, MD | Contact | 86-010-88322387 | jxj103@hotmail.com | |
| Hui Dong, MD | Contact | 86-010-88322387 | donghui666@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiongjing Jiang, MD | Fuwai Hospital, National Center for Cardiovascular Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33605538 | Result | Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19. | |
| 34398686 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Spironolactone | Drug | Patients will be treated with spironolactone. |
|
Change of office blood pressure at 1, 3, 6 months compared with baseline |
| 1, 3, 6 months after randomization |
| change of antihypertensive medication burden at 1, 3, 6 months compared with baseline | change of antihypertensive medication burden at 6 months compared with baseline | 1, 3, 6 months after randomization |
| Incidence of clinical events | Incidence of clinical events including: major adverse cardiovascular events(MACE), renal insufficiency, adrenal insufficiency, hyperkalemia, vascular complication, flank/back pain, gynecomastia, breast tenderness, sexual dysfunction,etc. | 6 months after randomization |
| Change of Serum potassium at 3, 6 months after randomization, compared with baseline | Change of Serum potassium at 3, 6 months compared with baseline | 3,6 months after randomization |
| Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline | Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline | 3, 6 months after randomization |
| Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline | Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline | 3, 6 months after randomization |
|
| Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| The First Affiliated Hospital of Chengdu Medical College | Recruiting | Chengdu | Sichuan | 610500 | China |
|
| Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available. |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided