Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study (SAAE-RH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Procedure: Superselective adrenal arterial embolization

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifei the second affiliated hospital of Nanchang university, Doctor; Phone Number: (0791)86209562; Email: yf_dong66@126.com

Study Locations

• China
  • Nanchang, China
    • Recruiting
    • The Second Affiliated Hospital of Nanchang University
    • Contact: Yifei Dong, doctorate; Phone Number: +8613576007061; Email: yf_dong66@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional treatment group; superselective adrenal arterial embolization

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.; Other Names: Transarterial embolization; Adrenal artery ablation; catheter-based adrenal ablation; Transcatheter Arterial Ablation; percutaneous adrenal arterial embolization; selective adrenal artery embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour mean systolic blood pressure	ambulatory blood pressure monitoring	8 weeks after SAAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with non-refractory hypertension	Describe how many patients are converted from refractory hypertension to non-refractory hypertension	8 weeks after SAAE
24-hour mean diastolic blood pressure	ambulatory blood pressure monitoring	8 weeks after SAAE
Safety monitoring:Procedure-related complications	Procedure-related complications include but are not limited to the following: transient arrhythmia during the SAAE procedure, incidence of hypertensive encephalopathy; post-procedure complications such as pleural effusion, brachial artery pseudoaneurysm, brachial artery thrombosis, pancreatitis, and contrast-induced nephropathy.	up to 8 weeks
Safety monitoring:Adrenal-related hormones	Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.	8 weeks after SAAE
Safety monitoring:Kidney function	Estimated Glomerular Filtration Rate	8 weeks after SAAE
Safety monitoring:Plasma electrolyte levels	Plasma potassium	8 weeks after SAAE

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime average systolic blood pressure	Daytime average systolic blood pressure	8 weeks after SAAE
Daytime average diastolic blood pressure	Daytime average diastolic blood pressure	8 weeks after SAAE
Nighttime average systolic blood pressure	Nighttime average systolic blood pressure	8 weeks after SAAE
Nighttime average diastolic blood pressure	Nighttime average diastolic blood pressure	8 weeks after SAAE

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Investigators: Principal Investigator: Yifei Dong, Doctor, Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Essential hypertension; Interventional therapy; Superselective adrenal arterial embolization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: IIT-2024-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No