Superselective Adrenal Arterial Embolization for Resistant Hypertension

First Affiliated Hospital of Chengdu Medical College

Status: Not yet enrolling

Conditions: Resistant Hypertension

Treatments: Procedure: SAAE; Drug: traditional triple antihypertensive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05552300

SAAE-RHT

Details and patient eligibility

About

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.

Full description

Not Provided

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Superselective adrenal arterial embolization

Experimental group

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

Treatment:

Drug: traditional triple antihypertensive treatment

Procedure: SAAE

Traditional triple antihypertensive treatment

Active Comparator group

Description:

No intervention, but treated with traditional triple antihypertensive treatment

Treatment:

Drug: traditional triple antihypertensive treatment