The Second Affiliated Hospital of Nanchang University
Nanchang, China
Location status: Recruiting
NCT Number: NCT06568640
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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Request Info18 year and older
All sexes
Interventional
Not applicable
Nanchang, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Adrenal artery ablation, catheter-based adrenal ablation, Transcatheter Arterial Ablation, Transarterial embolization, percutaneous adrenal arterial embolization, selective adrenal artery embolization
Time frame: 8 weeks after SAAE
ambulatory blood pressure monitoring
Time frame: 8 weeks after SAAE
Describe how many patients are converted from refractory hypertension to non-refractory hypertension
Time frame: 8 weeks after SAAE
ambulatory blood pressure monitoring
Time frame: up to 8 weeks
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: 8 weeks after SAAE
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
Estimated Glomerular Filtration Rate
Time frame: 8 weeks after SAAE
Plasma potassium
Time frame: 8 weeks after SAAE
Daytime average systolic blood pressure
Time frame: 8 weeks after SAAE
Daytime average diastolic blood pressure
Time frame: 8 weeks after SAAE
Nighttime average systolic blood pressure
Time frame: 8 weeks after SAAE
Nighttime average diastolic blood pressure
Contact information is provided by the study sponsor or research team.
Yifei the second affiliated hospital of Nanchang university, Doctor
CONTACT
Second Affiliated Hospital of Nanchang University
Other
Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
Acronym: SAAE-RH
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