NCT06282107Not yet recruiting
Effectiveness and Safety of BiSAAE for Resistant Hypertension.
Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Diseases
- High blood pressure
- NCT number
- NCT06282107
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Jan 2025 to the primary completion date, 30 Jun 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
Other illness
- Secondary hypertension
- Adrenergic insufficiency.
- adrenocortical insufficiency
- 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.
- 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
Lab values
- Renal failure eGFR\<60 mL/min/1.73 m2
- 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.
Other
- Fertile woman without contraceptives.
- Coagulation dysfunction.
- Pregnant women or lactating women.
Who the study is looking for
- 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.
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.