Status:
RECRUITING
Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
Lead Sponsor:
Second Affiliated Hospital of Nanchang University
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06568640
Start Date
August 1 2024
End Date
December 1 2027
Last Update
August 23 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Nanchang University
Nanchang, China