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

Launched by SECOND AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called superselective adrenal arterial embolization (SAAE) to see if it can help patients with a condition called essential refractory hypertension, which means their high blood pressure is difficult to control even with medication. The goal is to evaluate how safe and effective this procedure is for reducing blood pressure in patients who meet specific criteria. If you are over 18 years old, have been taking three different blood pressure medications without success, and have had high blood pressure for more than six months, you might be eligible to participate.

If you join the study, you will undergo the SAAE procedure, and then you will have follow-up visits for eight weeks to monitor how well the treatment is working and to check for any side effects. It's important to know that certain health conditions may exclude you from participating, such as severe kidney issues or certain heart problems. This trial is currently looking for participants, so if you or a loved one are struggling with high blood pressure and are interested in finding out more, consider discussing this study with your doctor.

Gender

ALL

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.