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Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intevention | Experimental | Adrenal Artery Ablation |
|
| Control | No Intervention | No intervention, but treated with standard anti-hypertensive drigs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular chemical Ablation of Adrenal Gland | Procedure | Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h average systolic blood pressure compared with the baseline | Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h average systolic blood pressure between two groups | Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of anti-hypertensive regimen between two groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change of testosterone and estrogen levels | Change of testosterone and estrogen levels compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of 24-h urine microalbumin, microalbumin/creatinine ratio |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third hospital affiliated to the Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059026 | Derived | Sun F, Hong Y, Zhang H, Liu X, Zhao Z, He H, Yan Z, Zhu Z. Determination of adrenal hypersecretion in primary Aldosteronism without aldosterone-production adenomas. BMC Endocr Disord. 2021 May 31;21(1):114. doi: 10.1186/s12902-021-00770-1. |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
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Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with conventional anti-hypertensive drugs
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Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (24 weeks) |
| 24 weeks |
| Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between two groups | Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of office systolic and diastolic pressure between two groups | Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of blood electrolytes(serum potassium and natrium in mmol/L) | Change of blood electrolytes(serum potassium and natrium in mmol/L) compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of plasma aldosterone and 24-h urine aldosterone | Change of plasma aldosterone and 24-h urine aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of plasma renin | Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of plasma cortisol and 24-h urine cortisol | Change of plasma cortisol and 24-h urine cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of liver enzymes (ALT, AST) | Change of liver enzymes (ALT, AST) compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of serum creatinine | Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of fasting blood glucose | Change of fasting blood glucose in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L | Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
Change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with baseline, and between the intervention and control group at the end of the study (24 weeks) |
| 24 weeks |
| Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) | Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of carotid intima-media thickness assessed by carotid ultrasound | Change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| Change of electrocardiogram manifestations | Change of electrocardiogram manifestations(heart rhythms, heart rates and arrhythmia ) compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 24 weeks |
| D002318 | Cardiovascular Diseases |