Superselective Adrenal Arterial Embolization for Resistant Hypertension
Primary Purpose
Resistant Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SAAE
traditional triple antihypertensive treatment
Sponsored by

About this trial
This is an interventional treatment trial for Resistant Hypertension
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Superselective adrenal arterial embolization
Traditional triple antihypertensive treatment
Arm Description
Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland Interventions: Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment
No intervention, but treated with traditional triple antihypertensive treatment
Outcomes
Primary Outcome Measures
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
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
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
Difference in the change of the number of antihypertensive medications between the intervention and control group
Change of home systolic and diastolic pressure
Difference in the change of home systolic and diastolic pressure between the intervention and control group
Change of office systolic and diastolic pressure
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Change of blood electrolytes (K+, Na +)
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Change of plasma aldosterone
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
Change of plasma cortisol
Difference in the change of plasma cortisol (nmol/L) between the intervention and control group
Change of plasma renin measured
Difference in the change of plasma renin (pg/ml) between the intervention and control group
Change of liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
Change of kidney function
Difference in the change of serum creatinine in umol/L between the intervention and control group
Change of fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
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
Change of 24-h urine microalbumin
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
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
Change of echocardiography parameters (LVEF)
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)
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
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
Full Information
NCT ID
NCT05552300
First Posted
September 11, 2022
Last Updated
September 20, 2022
Sponsor
First Affiliated Hospital of Chengdu Medical College
1. Study Identification
Unique Protocol Identification Number
NCT05552300
Brief Title
Superselective Adrenal Arterial Embolization for Resistant Hypertension
Official Title
Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Chengdu Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Not Provided
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Superselective adrenal arterial embolization
Arm Type
Experimental
Arm Description
Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland
Interventions:
Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment
Arm Title
Traditional triple antihypertensive treatment
Arm Type
Active Comparator
Arm Description
No intervention, but treated with traditional triple antihypertensive treatment
Intervention Type
Procedure
Intervention Name(s)
SAAE
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
traditional triple antihypertensive treatment
Intervention Description
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
Primary Outcome Measure Information:
Title
Change of 24-h average systolic blood pressure
Description
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
Time Frame
6-month
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
6-month
Title
Change of the number of antihypertensive medications
Description
Difference in the change of the number of antihypertensive medications between the intervention and control group
Time Frame
6-month
Title
Change of home systolic and diastolic pressure
Description
Difference in the change of home systolic and diastolic pressure between the intervention and control group
Time Frame
6-month
Title
Change of office systolic and diastolic pressure
Description
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Time Frame
6-month
Title
Change of blood electrolytes (K+, Na +)
Description
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Time Frame
6-month
Title
Change of plasma aldosterone
Description
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
Time Frame
6-month
Title
Change of plasma cortisol
Description
Difference in the change of plasma cortisol (nmol/L) between the intervention and control group
Time Frame
6-month
Title
Change of plasma renin measured
Description
Difference in the change of plasma renin (pg/ml) between the intervention and control group
Time Frame
6-month
Title
Change of liver enzymes
Description
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
Time Frame
6-month
Title
Change of kidney function
Description
Difference in the change of serum creatinine in umol/L between the intervention and control group
Time Frame
6-month
Title
Change of fasting blood glucose
Description
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
Time Frame
6-month
Title
Change of lipids profiles
Description
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group
Time Frame
6-month
Title
Change of 24-h urine microalbumin
Description
Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group
Time Frame
6-month
Title
Change of 24-h 24-h urine creatinine
Description
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
Time Frame
6-month
Title
Change of echocardiography parameters (LVEF)
Description
Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) between the intervention and control group
Time Frame
6-month
Title
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Description
Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group
Time Frame
6-month
Title
Change of carotid intima-media thickness
Description
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
Time Frame
6-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaqiong Zhou, MD
Phone
+8615184399329
Email
1273868593@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqiu M Yang
Phone
+8617380086816
Email
285965467@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peijian Wang
Organizational Affiliation
Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35268545
Citation
Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455.
Results Reference
result
PubMed Identifier
33605538
Citation
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.
Results Reference
result
PubMed Identifier
31183321
Citation
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.
Results Reference
result
PubMed Identifier
33116703
Citation
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.
Results Reference
result
PubMed Identifier
34398686
Citation
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.
Results Reference
result
Learn more about this trial
Superselective Adrenal Arterial Embolization for Resistant Hypertension
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