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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Essential Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study design is a single-center, open-label, self-controlled, single-arm, prospective study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional treatment group

superselective adrenal arterial embolization

Group Type EXPERIMENTAL

Superselective adrenal arterial embolization

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Adrenal artery ablation catheter-based adrenal ablation Transcatheter Arterial Ablation Transarterial embolization percutaneous adrenal arterial embolization selective adrenal artery embolization

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No