Clinical trial NCT05552300: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Resistant Hypertension
Lead sponsor: First Affiliated Hospital of Chengdu Medical College
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change of 24-h average systolic blood pressure
timeFrame: 6-month
Secondary outcomes:
measure: 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
timeFrame: 6-month
measure: Change of the number of antihypertensive medications
timeFrame: 6-month
measure: Change of home systolic and diastolic pressure
timeFrame: 6-month
measure: Change of office systolic and diastolic pressure
timeFrame: 6-month
measure: Change of blood electrolytes (K+, Na +)
timeFrame: 6-month
measure: Change of plasma aldosterone
timeFrame: 6-month
measure: Change of plasma cortisol
timeFrame: 6-month
measure: Change of plasma renin measured
timeFrame: 6-month
measure: Change of liver enzymes
timeFrame: 6-month
measure: Change of kidney function
timeFrame: 6-month
measure: Change of fasting blood glucose
timeFrame: 6-month
measure: Change of lipids profiles
timeFrame: 6-month
measure: Change of 24-h urine microalbumin
timeFrame: 6-month
measure: Change of 24-h 24-h urine creatinine
timeFrame: 6-month
measure: Change of echocardiography parameters (LVEF)
timeFrame: 6-month
measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
timeFrame: 6-month
measure: Change of carotid intima-media thickness
timeFrame: 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College
name: Peijian Wang
role: STUDY_CHAIR
References:
citation: Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455.
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.
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.
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.
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.