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Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. It is not uncommon, being identified in 10 to 30% of hypertensive patients and it is known to be a risk factor for cardiovascular (CV) events, including stroke, myocardial infarction (MI), heart failure (HF), and CV mortality, as well as adverse renal events,including chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system can play a pathogenic role in triggering and sustaining RH. 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. Therefore, SAAE is a minimally invasive procedure that might be used as an alternative strategy to antihypertensive drugs or reduce the intensity of antihypertensive drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superselective adrenal arterial embolization | Experimental | Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland Interventions: Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment |
|
| Traditional triple antihypertensive treatment | Active Comparator | No intervention, but treated with traditional triple antihypertensive treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAAE | Procedure | 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 |
| 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 |
| 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaqiong Zhou, MD | Contact | +8615184399329 | 1273868593@qq.com | |
| Yanqiu M Yang | Contact | +8617380086816 | 285965467@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Peijian Wang | Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35268545 | Result | Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455. | |
| 33605538 | Result | Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19. |
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| traditional triple antihypertensive treatment | Drug | irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
|
| 6-month |
| Change of the number of antihypertensive medications | Difference in the change of the number of antihypertensive medications 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 | 6-month |
| Change of office systolic and diastolic pressure | Difference in the change of office systolic and diastolic pressure between the intervention and control group | 6-month |
| Change of blood electrolytes (K+, Na +) | Difference in the change of blood electrolytes (K+, Na + in mmol/L) 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 | 6-month |
| Change of plasma cortisol | Difference in the change of plasma cortisol (nmol/L) 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 | 6-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 kidney function | Difference in the change of serum creatinine in umol/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 | 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 | 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 | 6-month |
| Change of 24-h 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 echocardiography parameters (LVEF) | Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) 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 | 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 | 6-month |
| 31183321 | Result | Giurazza F, Corvino F, Silvestre M, Cangiano G, Cavaglia E, Amodio F, De Magistris G, Frauenfelder G, Niola R. Adrenal glands hemorrhages: embolization in acute setting. Gland Surg. 2019 Apr;8(2):115-122. doi: 10.21037/gs.2018.10.06. |
| 33116703 | Result | Zhou Q, Liu X, Zhang H, Zhao Z, Li Q, He H, Zhu Z, Yan Z. Adrenal Artery Ablation for the Treatment of Hypercortisolism Based on Adrenal Venous Sampling: A Potential Therapeutic Strategy. Diabetes Metab Syndr Obes. 2020 Oct 6;13:3519-3525. doi: 10.2147/DMSO.S262092. eCollection 2020. |
| 34398686 | Result | Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available. |