Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
Recruiting · NCT06568640 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Nanchang University
View the official record on ClinicalTrials.gov →Interventions studied
Superselective adrenal arterial embolization
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The Second Affiliated Hospital of Nanchang University - Nanchang, China