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Hypertension is a common problem, affecting >1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral superselective adrenal arterial embolization | Experimental | Selectively injects 1.5-2.5 mL ethanol into bilateral adrenal artery to ablate part of the adrenal gland; irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
|
| traditional triple antihypertensive treatment | Active Comparator | irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiSAAE | Procedure | SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h average systolic blood pressure | Difference in the change of 24-h average systolic blood pressure between the intervention and control group | 6-month |
| Change of 24-h average systolic blood pressure | Difference in the change of 24-h average systolic blood pressure between the intervention and control group | 12-month |
| Change of 24-h average systolic blood pressure | Difference in the change of 24-h average systolic blood pressure between the intervention and control group | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
History of depression, schizophrenia or vascular dementia.
-Refused to sign informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaqiong Zhou | Contact | +8615184399329 | 1273868593@qq.com | |
| Peijian Wang | Contact | +861880718263 | wpjmed@aliyun.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37789113 | Background | Wang X, Luo T, Yang Y, Zhou Y, Hou J, Wang P. Unilateral chemical ablation of the adrenal gland lowers blood pressure and alleviates target organ damage in spontaneously hypertensive rats. Hypertens Res. 2023 Dec;46(12):2693-2704. doi: 10.1038/s41440-023-01444-2. Epub 2023 Oct 3. | |
| 37644179 | Background | Zhou Y, Wang X, Hou J, Wan J, Yang Y, Liu S, Luo T, Liu Q, Xue Q, Wang P. A controlled trial of percutaneous adrenal arterial embolization for hypertension in patients with idiopathic hyperaldosteronism. Hypertens Res. 2024 Feb;47(2):311-321. doi: 10.1038/s41440-023-01420-w. Epub 2023 Aug 29. |
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| traditional triple antihypertensive treatment | Procedure | traditional triple antihypertensive treatment |
|
| 6-month |
| 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 | 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 | 3-month |
| 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 | 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 | 12-month |
| Change of home systolic and diastolic pressure | Difference in the change of home systolic and diastolic pressure between the intervention and control group | 6-month |
| Change of home systolic and diastolic pressure | Difference in the change of home systolic and diastolic pressure between the intervention and control group | 12-month |
| Change of home systolic and diastolic pressure | Difference in the change of home systolic and diastolic pressure between the intervention and control group | 3-month |
| Difference in the change of office systolic and diastolic pressure between the intervention and control group | Difference in the change of office systolic and diastolic pressure between the intervention and control group | 6-month |
| Difference in the change of office systolic and diastolic pressure between the intervention and control group | Difference in the change of office systolic and diastolic pressure between the intervention and control group | 12-month |
| Difference in the change of office systolic and diastolic pressure between the intervention and control group | Difference in the change of office systolic and diastolic pressure between the intervention and control group | 3-month |
| Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | 6-month |
| Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | 12-month |
| Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group | 3-month |
| Change of plasma aldosterone | Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group | 6-month |
| Change of plasma aldosterone | Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group | 12-month |
| Change of plasma aldosterone | Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group | 3-month |
| Change of plasma cortisol | Change of plasma cortisol | 6-month |
| Change of plasma cortisol | Change of plasma cortisol | 12-month |
| Change of plasma cortisol | Change of plasma cortisol | 3-month |
| Change of plasma renin measured | Difference in the change of plasma renin (pg/ml) between the intervention and control group | 6-month |
| Change of plasma renin measured | Difference in the change of plasma renin (pg/ml) between the intervention and control group | 12-month |
| Change of plasma renin measured | Difference in the change of plasma renin (pg/ml) between the intervention and control group | 3-month |
| Change of liver enzymes | Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group | 6-month |
| Change of liver enzymes | Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group | 12-month |
| Change of liver enzymes | Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group | 3-month |
| Change of kidney function | Difference in the change of serum creatinine in umol/L between the intervention and control group | 6-month |
| Change of kidney function | Difference in the change of serum creatinine in umol/L between the intervention and control group | 12-month |
| Change of kidney function | Difference in the change of serum creatinine in umol/L between the intervention and control group | 3-month |
| Change of fasting blood glucose | Difference in the change of fasting blood glucose in mmol/L between the intervention and control group | 6-month |
| Change of fasting blood glucose | Difference in the change of fasting blood glucose in mmol/L between the intervention and control group | 3-month |
| Change of fasting blood glucose | Difference in the change of fasting blood glucose in mmol/L between the intervention and control group | 12-month |
| Change of lipids profiles | Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group | 6-month |
| Change of lipids profiles | Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group | 12-month |
| Change of lipids profiles | Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group | 3-month |
| Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) | Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group | 6-month |
| Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) | Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group | 12-month |
| Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) | Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group | 3-month |
| Change of 24-h urine microalbumin | Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group | 6-month |
| Change of 24-h urine microalbumin | Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group | 12-month |
| Change of 24-h urine microalbumin | Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group | 3-month |
| Change of 24-h urine creatinine | Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group | 6-month |
| Change of 24-h urine creatinine | Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group | 12-month |
| Change of 24-h urine creatinine | Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group | 3-month |
| Change of echocardiography parameters (LVEF) | Change of echocardiography parameters (LVEF) | 6-month |
| Change of echocardiography parameters (LVEF) | Change of echocardiography parameters (LVEF) | 12-month |
| Change of echocardiography parameters (LVEF) | Change of echocardiography parameters (LVEF) | 3-month |
| Change of carotid intima-media thickness | Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group | 6-month |
| Change of carotid intima-media thickness | Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group | 12-month |
| Change of carotid intima-media thickness | Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group | 3-month |
| 36304542 | Background | Zhou Y, Wang D, Liu Q, Hou J, Wang P. Case report: Percutaneous adrenal arterial embolization cures resistant hypertension. Front Cardiovasc Med. 2022 Oct 11;9:1013426. doi: 10.3389/fcvm.2022.1013426. eCollection 2022. |
| 36205513 | Background | Zhou Y, Liu Q, Wang X, Wan J, Liu S, Luo T, He P, Hou J, Pu J, Wang D, Liang D, Yang Y, Wang P. Adrenal Ablation Versus Mineralocorticoid Receptor Antagonism for the Treatment of Primary Aldosteronism: A Single-Center Prospective Cohort Study. Am J Hypertens. 2022 Dec 8;35(12):1014-1023. doi: 10.1093/ajh/hpac105. |