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The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.
After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAAE group | Experimental | Subjects received super selective adrenal artery embolization treatment |
|
| Spironolactone group | Active Comparator | Subjects received spironolactone treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super selective adrenal artery embolization | Other | Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| LVMI | Left ventricular mass index(LVMI) | 12 months after SAAE |
| Measure | Description | Time Frame |
|---|---|---|
| LVH | left ventricular hypertrophy | 12 months after SAAE |
| ABPM | 24-hour ambulatory blood pressure monitor | 1 month after SAAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei Dong, Doctorate | Contact | +8613576007061 | yf_dong66@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifei Dong, Doctorate | Second Affiliated Hospital of Nanchang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
| Spironolactone | Drug | Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism. |
|
| ABPM | 24-hour ambulatory blood pressure monitor | 12 months after SAAE |
| PAC | plasma aldosterone concentration | 1 month after SAAE |
| PAC | plasma aldosterone concentration | 12 months after SAAE |
| PRA | plasma renin activity | 1 month after SAAE |
| PRA | plasma renin activity | 12 months after SAAE |
| ARR | aldosterone-to-renin ratio | 1 month after SAAE |
| ARR | aldosterone-to-renin ratio | 12 months after SAAE |
| Serum potassium | Serum potassium | 1 month after SAAE |
| Serum potassium | Serum potassium | 12 months after SAAE |
| serum creatinine | serum creatinine | 1 month after SAAE |
| serum creatinine | serum creatinine | 12 months after SAAE |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |