Effectiveness and Safety of BiSAAE 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (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. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Superselective Adrenal Arterial Embolization for Resistant Hypertension

NCT05552300

Resistant Hypertension

UNKNOWN NA

Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study

NCT06568640

Essential Hypertension

RECRUITING NA

Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization

NCT06228677

Resistant Hypertension Secondary Hypertension Secondary Hypertension to Endocrine Disorders +1 more

RECRUITING

The Diagnosis and Treatment of Resistant Hypertension, the Prevalence and the Prognosis

NCT01703780

Hypertension, Resistant to Conventional Therapy

UNKNOWN

Renal Sympathetic Denervation Combined With Aorticorenal Ganglion Ablation for Treatment of Hypertension

NCT06864962

Aorticorenal Ganglion Renal Sympathetic Denervation Autonomic Regulation +1 more

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resistant Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bilateral superselective adrenal arterial embolization

Selectively injects 1.5-2.5 mL ethanol into bilateral adrenal artery to ablate part of the adrenal gland; irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Group Type EXPERIMENTAL

BiSAAE

Intervention Type PROCEDURE

SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines

traditional triple antihypertensive treatment

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Group Type ACTIVE_COMPARATOR

traditional triple antihypertensive treatment

Intervention Type PROCEDURE

traditional triple antihypertensive treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BiSAAE

SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines

Intervention Type PROCEDURE

traditional triple antihypertensive treatment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, aged between 30-65 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

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No