Superselective Adrenal Arterial Embolization for Resistant Hypertension
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Not Provided
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Superselective adrenal arterial embolization 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
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
Drug: traditional triple antihypertensive treatment
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
|
| Active Comparator: Traditional triple antihypertensive treatment No intervention, but treated with traditional triple antihypertensive treatment |
Drug: traditional triple antihypertensive treatment
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
|
Outcome Measures
Primary Outcome Measures
- Change of 24-h average systolic blood pressure [6-month]
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
Secondary Outcome Measures
- 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 [6-month]
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
- Change of the number of antihypertensive medications [6-month]
Difference in the change of the number of antihypertensive medications between the intervention and control group
- Change of home systolic and diastolic pressure [6-month]
Difference in the change of home systolic and diastolic pressure between the intervention and control group
- Change of office systolic and diastolic pressure [6-month]
Difference in the change of office systolic and diastolic pressure between the intervention and control group
- Change of blood electrolytes (K+, Na +) [6-month]
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
- Change of plasma aldosterone [6-month]
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
- Change of plasma cortisol [6-month]
Difference in the change of plasma cortisol (nmol/L) between the intervention and control group
- Change of plasma renin measured [6-month]
Difference in the change of plasma renin (pg/ml) between the intervention and control group
- Change of liver enzymes [6-month]
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
- Change of kidney function [6-month]
Difference in the change of serum creatinine in umol/L between the intervention and control group
- Change of fasting blood glucose [6-month]
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
- Change of lipids profiles [6-month]
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group
- Change of 24-h urine microalbumin [6-month]
Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group
- Change of 24-h 24-h urine creatinine [6-month]
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
- Change of echocardiography parameters (LVEF) [6-month]
Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) between the intervention and control group
- Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) [6-month]
Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group
- Change of carotid intima-media thickness [6-month]
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- First Affiliated Hospital of Chengdu Medical College
Investigators
- Study Chair: Peijian Wang, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAAE-RHT