Treatment for severe high blood pressure using targeted artery blockage

Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study

This study is testing a new procedure to see if blocking specific arteries can help people with severe high blood pressure that hasn't improved with regular medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang)
• Trial ID: NCT06568640 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of superselective adrenal arterial embolization (SAAE) in patients suffering from primary refractory hypertension, which is high blood pressure that does not respond to standard treatments. It is a single-center, open-label, self-controlled, single-arm, prospective study involving patients who have been on multiple antihypertensive medications without success. After the SAAE procedure, participants will be monitored for 8 weeks to assess the outcomes of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with primary refractory hypertension who have been on multiple antihypertensive medications and have not achieved adequate blood pressure control.

Not a fit: Patients with certain medical conditions such as uncontrolled diabetes, severe heart or liver issues, or recent history of serious cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with severe hypertension that is resistant to conventional therapies.

How similar studies have performed: While this approach is innovative, similar studies exploring targeted embolization techniques for hypertension have shown promise, suggesting potential for success.

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.

Where this trial is running

Nanchang

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

Study contacts

• Principal investigator: Yifei Dong, Doctor — Second Affiliated Hospital of Nanchang University
• Study coordinator: Yifei the second affiliated hospital of Nanchang university, Doctor

Conditions Essential Hypertension; Essential hypertension; Superselective adrenal arterial embolization; Interventional therapy