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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Superselective adrenal arterial embolization

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Interventional treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

24-hour mean systolic blood pressure

ambulatory blood pressure monitoring

Time frame
8 weeks after SAAE

Secondary outcomes

1

Proportion of patients with non-refractory hypertension

Describe how many patients are converted from refractory hypertension to non-refractory hypertension

Time frame
8 weeks after SAAE
2

24-hour mean diastolic blood pressure

ambulatory blood pressure monitoring

Time frame
8 weeks after SAAE
3

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.

Time frame
up to 8 weeks
4

Safety monitoring:Adrenal-related hormones

Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.

Time frame
8 weeks after SAAE

Other outcomes

1

Daytime average systolic blood pressure

Daytime average systolic blood pressure

Time frame
8 weeks after SAAE
2

Daytime average diastolic blood pressure

Daytime average diastolic blood pressure

Time frame
8 weeks after SAAE
3

Nighttime average systolic blood pressure

Nighttime average systolic blood pressure

Time frame
8 weeks after SAAE
4

Nighttime average diastolic blood pressure

Nighttime average diastolic blood pressure

Time frame
8 weeks after SAAE

Sponsors and contacts

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