protocolSection identificationModule nctId: NCT06282107, orgStudyIdInfo id: BiSAAE-RHT, briefTitle: Effectiveness and Safety of BiSAAE for Resistant Hypertension., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chengdu Medical College, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Resistant Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: BiSAAE, interventions name: traditional triple antihypertensive treatment, outcomesModule primaryOutcomes measure: Change of 24-h average systolic blood pressure, primaryOutcomes measure: Change of 24-h average systolic blood pressure, primaryOutcomes measure: Change of 24-h average systolic blood pressure, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of carotid intima-media thickness, secondaryOutcomes measure: Change of carotid intima-media thickness, secondaryOutcomes measure: Change of carotid intima-media thickness, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False