Effectiveness and Safety of BiSAAE for Resistant Hypertension.

Launched by FIRST AFFILIATED HOSPITAL OF CHENGDU MEDICAL COLLEGE · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called bilateral superselective adrenal arterial embolization (SAAE) for people with resistant hypertension. Resistant hypertension is when a person's blood pressure remains high despite trying three or more different blood pressure medications and making lifestyle changes. The goal of this study is to see if this new procedure, which targets the adrenal glands to reduce hormones that raise blood pressure, is effective and safe compared to just using medications.

To be eligible for the study, participants must be between 30 and 65 years old and have high blood pressure that doesn’t respond to standard treatments. They should have already been taking a combination of three antihypertensive medications for at least four weeks. Participants can expect to undergo a procedure that involves a catheter to treat their hypertension, along with regular monitoring throughout the trial. It’s important to note that certain health conditions, such as heart failure or severe liver problems, may prevent someone from participating. This trial is currently not recruiting participants, but it aims to provide valuable information on new ways to help those struggling with stubborn high blood pressure.

Gender

ALL

Eligibility criteria

• 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