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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional treatment group | Experimental | superselective adrenal arterial embolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour mean systolic blood pressure | ambulatory blood pressure monitoring | 8 weeks after SAAE |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifei the second affiliated hospital of Nanchang university, Doctor | Contact | (0791)86209562 | yf_dong66@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifei Dong, Doctor | Second Affiliated Hospital of Nanchang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The study design is a single-center, open-label, self-controlled, single-arm, prospective study.
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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 |
| 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 |