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

NCT06568640 | Recruiting

• 1 other identifier: IIT-2024-109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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) 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

Essential Hypertension

Keywords

Essential hypertension; Superselective adrenal arterial embolization; Interventional therapy

Outcome Measures

Primary Outcomes (1)

• 24-hour mean systolic blood pressure

  ambulatory blood pressure monitoring

  8 weeks after SAAE

Secondary Outcomes (6)

• Proportion of patients with non-refractory hypertension

  8 weeks after SAAE

• 24-hour mean diastolic blood pressure

  8 weeks after SAAE

• Safety monitoring:Procedure-related complications

  up to 8 weeks

• Safety monitoring:Adrenal-related hormones

  8 weeks after SAAE

• Safety monitoring:Kidney function

  8 weeks after SAAE

Other Outcomes (4)

• Daytime average systolic blood pressure

  8 weeks after SAAE

• Daytime average diastolic blood pressure

  8 weeks after SAAE

• Nighttime average systolic blood pressure

  8 weeks after SAAE

Study Arms (1)

Interventional treatment group

EXPERIMENTAL

superselective adrenal arterial embolization

Procedure: Superselective adrenal arterial embolization

Interventions

Superselective adrenal arterial embolization 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.

Also known as: Adrenal artery ablation, catheter-based adrenal ablation, Transcatheter Arterial Ablation, Transarterial embolization, percutaneous adrenal arterial embolization, selective adrenal artery embolization

Interventional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yifei Dong, Doctor

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifei the second affiliated hospital of Nanchang university, Doctor

CONTACT

(0791)86209562; yf_dong66@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Cardiology

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

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)