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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
First Affiliated Hospital of Chengdu Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 11, 2022
    Last Updated
    September 20, 2022
    Sponsor
    First Affiliated Hospital of Chengdu Medical College
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    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

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    Superselective Adrenal Arterial Embolization for Resistant Hypertension

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