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

Not Applicable

Recruiting

• Conditions: Essential Hypertension
• Interventions: Procedure: Superselective adrenal arterial embolization

• Registration Number: NCT06568640
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

Brief Summary

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.

Detailed Description

The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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;
• Signed informed consent form.

Exclusion Criteria

• 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;
• Adrenal mass with a diameter exceeding 2 cm;
• Severe allergy to contrast agents;
• Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional treatment group	Superselective adrenal arterial embolization	superselective adrenal arterial embolization

Primary Outcome Measures

Name	Time	Method
24-hour mean systolic blood pressure	8 weeks after SAAE	ambulatory blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Safety monitoring:Procedure-related complications	up to 8 weeks	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	8 weeks after SAAE	Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.
Proportion of patients with non-refractory hypertension	8 weeks after SAAE	Describe how many patients are converted from refractory hypertension to non-refractory hypertension
24-hour mean diastolic blood pressure	8 weeks after SAAE	ambulatory blood pressure monitoring
Safety monitoring:Kidney function	8 weeks after SAAE	Estimated Glomerular Filtration Rate
Safety monitoring:Plasma electrolyte levels	8 weeks after SAAE	Plasma potassium

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China