Effectiveness and Safety of BiSAAE for Resistant Hypertension.
Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Yaqiong Zhou
- Phone Number: +8615184399329
- Email: 1273868593@qq.com
Study Contact Backup
- Name: Peijian Wang
- Phone Number: +861880718263
- Email: wpjmed@aliyun.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged between 30-65 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Bilateral superselective adrenal arterial embolization
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
|
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
|
|
Active Comparator: traditional triple antihypertensive treatment
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
|
traditional triple antihypertensive treatment
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of 24-h average systolic blood pressure
Time Frame: 6-month
|
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
Time Frame: 12-month
|
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
Time Frame: 3-month
|
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
|
3-month
|
Secondary Outcome Measures
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
Time Frame: 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
|
6-month
|
|
Change of home systolic and diastolic pressure
Time Frame: 6-month
|
Difference in the change of home systolic and diastolic pressure between the intervention and control group
|
6-month
|
|
Change of plasma aldosterone
Time Frame: 6-month
|
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
|
6-month
|
|
Change of plasma renin measured
Time Frame: 6-month
|
Difference in the change of plasma renin (pg/ml) between the intervention and control group
|
6-month
|
|
Change of liver enzymes
Time Frame: 6-month
|
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
|
6-month
|
|
Change of kidney function
Time Frame: 6-month
|
Difference in the change of serum creatinine in umol/L between the intervention and control group
|
6-month
|
|
Change of fasting blood glucose
Time Frame: 6-month
|
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
|
6-month
|
|
Change of lipids profiles
Time Frame: 6-month
|
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
Time Frame: 6-month
|
Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group
|
6-month
|
|
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Time Frame: 6-month
|
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
Time Frame: 6-month
|
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
|
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
Time Frame: 3-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
|
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
Time Frame: 12-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
|
12-month
|
|
Change of home systolic and diastolic pressure
Time Frame: 12-month
|
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
Time Frame: 3-month
|
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
Time Frame: 6-month
|
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
Time Frame: 12-month
|
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
Time Frame: 3-month
|
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
Time Frame: 6-month
|
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
Time Frame: 12-month
|
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
Time Frame: 3-month
|
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
|
3-month
|
|
Change of plasma aldosterone
Time Frame: 12-month
|
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
|
12-month
|
|
Change of plasma aldosterone
Time Frame: 3-month
|
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
|
3-month
|
|
Change of plasma cortisol
Time Frame: 6-month
|
Change of plasma cortisol
|
6-month
|
|
Change of plasma cortisol
Time Frame: 12-month
|
Change of plasma cortisol
|
12-month
|
|
Change of plasma cortisol
Time Frame: 3-month
|
Change of plasma cortisol
|
3-month
|
|
Change of plasma renin measured
Time Frame: 12-month
|
Difference in the change of plasma renin (pg/ml) between the intervention and control group
|
12-month
|
|
Change of plasma renin measured
Time Frame: 3-month
|
Difference in the change of plasma renin (pg/ml) between the intervention and control group
|
3-month
|
|
Change of liver enzymes
Time Frame: 12-month
|
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
|
12-month
|
|
Change of liver enzymes
Time Frame: 3-month
|
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
|
3-month
|
|
Change of kidney function
Time Frame: 12-month
|
Difference in the change of serum creatinine in umol/L between the intervention and control group
|
12-month
|
|
Change of kidney function
Time Frame: 3-month
|
Difference in the change of serum creatinine in umol/L between the intervention and control group
|
3-month
|
|
Change of fasting blood glucose
Time Frame: 3-month
|
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
|
3-month
|
|
Change of fasting blood glucose
Time Frame: 12-month
|
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
|
12-month
|
|
Change of lipids profiles
Time Frame: 12-month
|
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
Time Frame: 3-month
|
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)
Time Frame: 12-month
|
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)
Time Frame: 3-month
|
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
Time Frame: 12-month
|
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
Time Frame: 3-month
|
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
Time Frame: 6-month
|
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
Time Frame: 12-month
|
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
Time Frame: 3-month
|
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
|
3-month
|
|
Change of echocardiography parameters (LVEF)
Time Frame: 6-month
|
Change of echocardiography parameters (LVEF)
|
6-month
|
|
Change of echocardiography parameters (LVEF)
Time Frame: 12-month
|
Change of echocardiography parameters (LVEF)
|
12-month
|
|
Change of echocardiography parameters (LVEF)
Time Frame: 3-month
|
Change of echocardiography parameters (LVEF)
|
3-month
|
|
Change of carotid intima-media thickness
Time Frame: 12-month
|
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
Time Frame: 3-month
|
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
|
3-month
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- BiSAAE-RHT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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