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

Recruiting now · Not applicable

Conditions studied: Essential Hypertension

In brief

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.

Key facts

Study ID

NCT06568640

Run by

Second Affiliated Hospital of Nanchang University

People needed

20

Starts

2024-08-01

Expected to finish

2027-12-01

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Nanchang University — Nanchang, China (enrolling)

Full record on ClinicalTrials.gov

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