About this trial
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years, no gender restrictions;
Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
Duration of hypertension greater than 6 months;
Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
Disqualifiers
Morning cortisol level < 4.3 µg/dL; estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; serum potassium level > 5.5 mmol/L;
Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
Pregnant women or those planning to conceive within the next year;
Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
Trial design
Single group
Treatments tested in this trial
Superselective adrenal arterial embolization
Procedure/SurgerySuperselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.
Treatment groups
Trial outcomes
Primary outcomes
24-hour mean systolic blood pressure
ambulatory blood pressure monitoring
Secondary outcomes
Proportion of patients with non-refractory hypertension
Describe how many patients are converted from refractory hypertension to non-refractory hypertension
24-hour mean diastolic blood pressure
ambulatory blood pressure monitoring
Safety monitoring:Procedure-related complications
Procedure-related complications include but are not limited to the following: transient arrhythmia during the SAAE procedure, incidence of hypertensive encephalopathy; post-procedure complications such as pleural effusion, brachial artery pseudoaneurysm, brachial artery thrombosis, pancreatitis, and contrast-induced nephropathy.
Safety monitoring:Adrenal-related hormones
Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.
Other outcomes
Daytime average systolic blood pressure
Daytime average systolic blood pressure
Daytime average diastolic blood pressure
Daytime average diastolic blood pressure
Nighttime average systolic blood pressure
Nighttime average systolic blood pressure
Nighttime average diastolic blood pressure
Nighttime average diastolic blood pressure
Sponsors and contacts
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