Superselective Adrenal Arterial Embolization for Resistant Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Not Provided

Conditions

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Resistant Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

SAAE

Intervention Type PROCEDURE

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

traditional triple antihypertensive treatment

Intervention Type DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Traditional triple antihypertensive treatment

No intervention, but treated with traditional triple antihypertensive treatment

Group Type ACTIVE_COMPARATOR

traditional triple antihypertensive treatment

Intervention Type DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Interventions

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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

Intervention Type PROCEDURE

traditional triple antihypertensive treatment

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No