Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Superselective adrenal arterial embolization.
- Who it may be relevant to
- Registry conditions: Essential Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure Superselective adrenal arterial embolization
Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.
Primary outcome measures
- 24-hour mean systolic blood pressure [Time frame: 8 weeks after SAAE]
Secondary outcome measures (6)
- Proportion of patients with non-refractory hypertension [Time frame: 8 weeks after SAAE]
- 24-hour mean diastolic blood pressure [Time frame: 8 weeks after SAAE]
- Safety monitoring:Procedure-related complications [Time frame: up to 8 weeks]
- Safety monitoring:Adrenal-related hormones [Time frame: 8 weeks after SAAE]
- Safety monitoring:Kidney function [Time frame: 8 weeks after SAAE]
- Safety monitoring:Plasma electrolyte levels [Time frame: 8 weeks after 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Nanchang University — Nanchang
Identifiers
NCT: NCT06568640 · IIT-2024-109