Superselective Adrenal Arterial Embolization for Resistant Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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Not Provided

Official Title
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Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Procedure: SAAE
* Drug: traditional triple antihypertensive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged between 18-65 years old. Patients with resist hypertension (office systolic blood pressure ≥140 mmHg, and/or office diastolic blood pressure ≥90 mmHg, and/or 24-h average systolic blood pressure ≥130 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 4 weeks. Informed consent signed and agreed to participate in this trial. Exclusion Criteria: Secondary hypertension Adrenergic insufficiency. adrenocortical insufficiency Renal failure eGFR<60 mL/min/1.73 m2 Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events. Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts. Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history. Fertile woman without contraceptives. Coagulation dysfunction. Pregnant women or lactating women. Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial. Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug. Allergy or any contraindications for the study drugs, contrast agents and alcohol. History of depression, schizophrenia or vascular dementia. Refused to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superselective adrenal arterial embolization<br>Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland Interventions: Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment | Procedure: SAAE<br>* 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<br>Drug: traditional triple antihypertensive treatment<br>* irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d<br>|
| Active Comparator: Traditional triple antihypertensive treatment<br>No intervention, but treated with traditional triple antihypertensive treatment | Drug: traditional triple antihypertensive treatment<br>* irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |