Superselective Adrenal Arterial Embolization for Resistant Hypertension

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Chengdu Medical College
• Treatments: Antihypertensive Agents

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