Clinical trial NCT06568640: Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
Official title: Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Essential Hypertension
Keywords: Essential hypertension
Superselective adrenal arterial embolization
Interventional therapy
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a single-center, open-label, self-controlled, single-arm, prospective study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hour mean systolic blood pressure
timeFrame: 8 weeks after SAAE
Secondary outcomes:
measure: Proportion of patients with non-refractory hypertension
timeFrame: 8 weeks after SAAE
measure: 24-hour mean diastolic blood pressure
timeFrame: 8 weeks after SAAE
measure: Safety monitoring:Procedure-related complications
timeFrame: up to 8 weeks
measure: Safety monitoring:Adrenal-related hormones
timeFrame: 8 weeks after SAAE
measure: Safety monitoring:Kidney function
timeFrame: 8 weeks after SAAE
measure: Safety monitoring:Plasma electrolyte levels
timeFrame: 8 weeks after SAAE
Other outcomes:
measure: Daytime average systolic blood pressure
timeFrame: 8 weeks after SAAE
measure: Daytime average diastolic blood pressure
timeFrame: 8 weeks after SAAE
measure: Nighttime average systolic blood pressure
timeFrame: 8 weeks after SAAE
measure: Nighttime average diastolic blood pressure
timeFrame: 8 weeks after SAAE
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Yifei Dong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: