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The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Selective endovascular chemical ablation of adrenal gland after adrenal angiography. |
|
| Control | Active Comparator | No intervention, but treated with standard antihypertensive drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective endovascular chemical ablation of adrenal gland | Procedure | Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h average systolic blood pressure measured at baseline and the end of the trial | Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed. | 24 weeks |
| 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 |
| Change of anti-hypertensive regimen measured at baseline and the end of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Change of sex hormones measured at baseline and the end of the trial | Difference in the change of 17-OH, DHEAS, testosterone and estrogen levels between the intervention and control group is to be analysed. | 24 weeks |
| Change of 24-h urine microalbumin measured at baseline and the end of the trial |
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 | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| Traditional triple antihypertensive treatment | Drug | irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
|
Difference in the change of anti-hypertensive regimen between the intervention and control group is to be analysed. |
| 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 measured at baseline and the end of the trial | Difference in the 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 is to be analysed. | 24 weeks |
| Change of home systolic and diastolic pressure measured at baseline and the end of the trial | Difference in the change of home systolic and diastolic pressure between the intervention and control group is to be analysed. | 24 weeks |
| Change of office systolic and diastolic pressure measured at baseline and the end of the trial | Difference in the change of office systolic and diastolic pressure between the intervention and control group is to be analysed. | 24 weeks |
| Change of blood electrolytes measured at baseline and the end of the trial | Difference in the change of blood electrolytes between the intervention and control group is to be analysed. | 24 weeks |
| Change of plasma and urine adrenal hormones measured at baseline and the end of the trial | Difference in the change of plasma and urine adrenal hormones between the intervention and control group is to be analysed. | 24 weeks |
| Change of plasma renin measured at baseline and the end of the trial | Difference in the change of plasma renin between the intervention and control group is to be analysed. | 24 weeks |
| Change of liver enzymes measured at baseline and the end of the trial | Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group is to be analysed. | 24 weeks |
| Change of kidney function measured at baseline and the end of the trial | Difference in the change of serum creatinine in umol/L between the intervention and control group is to be analysed. | 24 weeks |
| Change of fasting blood glucose measured at baseline and the end of the trial | Difference in the change of fasting blood glucose in mmol/L between the intervention and control group is to be analysed. | 24 weeks |
| Change of lipids profiles measured at baseline and the end of the trial | Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group is to be analysed. | 24 weeks |
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio between the intervention and control group is to be analysed. |
| 24 weeks |
| Change of echocardiography measured at baseline and the end of the trial | Difference in the change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre(mm), and LVEF(%), LVM in gram) between the intervention and control group is to be analysed. | 24 weeks |
| Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial | Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group is to be analysed. | 24 weeks |