drugset / Trial / NCT05552300

Superselective Adrenal Arterial Embolization for Resistant Hypertension

NCT05552300

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-10-01
Primary completion
2024-10-01
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Background Amlodipine Other / unclassified 5 mg
Background irbesartanhydrochlorothiazide Unknown 162.5 mg