Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study (SAAE-RH)

Nanchang University

Status

Enrolling

Conditions

Essential Hypertension

Treatments

Procedure: Superselective adrenal arterial embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT06568640

IIT-2024-109

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.