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The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin combined with Amlodipine besylate | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months |
|
| Simvastatin combined with Spironolactone and Amlodipine besylate. | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months |
|
| Amlodipine besylate combined with Spironolactone | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin combined with Amlodipine besylate | Drug | 6-month treatment of Simvastatin combined with Amlodipine besylate |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in plasma aldosterone levels | blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml) | 6 month |
| changes in 24-hour urinary aldosterone levels | 24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| changes in office blood pressure and home blood pressure | Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups | 6 month |
| changes in serum potassium levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sun fang | Contact | +862368729587 | sun_fang2007@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| Simvastatin combined with Spironolactone and Amlodipine besylate. | Drug | 6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate. |
|
| Amlodipine besylate combined Spironolactone | Drug | 6-month treatment of Amlodipine besylate combined with Spironolactone |
|
blood samples are collected at baseline and 6 months after treatment to measure serum potassium levels， and compare between groups and within groups (mmol/L)
| 6 month |
| changes in serum renin level | blood samples are collected at baseline and 6 months after treatment to measure serum renin levels, and compare between groups and within groups (mU/L) | 6 month |
| changes in plasma cholesterol levels | blood samples are collected at baseline and 6 months after treatment to measure plasma cholesterol levels， and compare between groups and within groups (mmol/L) | 6 month |
| changes in blood glucose | blood samples are collected at baseline and 6 months after treatment to measure blood glucose， and compare between groups and within groups (mmol/L) | 6 month |
| 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 |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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