Essential Hypertension
Conditions
Keywords
Essential hypertension, Superselective adrenal arterial embolization, Interventional therapy
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.
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.
Interventions
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.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study design is a single-center, open-label, self-controlled, single-arm, prospective study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour mean systolic blood pressure | 8 weeks after SAAE | ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour mean diastolic blood pressure | 8 weeks after SAAE | ambulatory blood pressure monitoring |
| Safety monitoring:Procedure-related complications | 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. |
| Safety monitoring:Adrenal-related hormones | 8 weeks after SAAE | Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels. |
| Safety monitoring:Kidney function | 8 weeks after SAAE | Estimated Glomerular Filtration Rate |
| Safety monitoring:Plasma electrolyte levels | 8 weeks after SAAE | Plasma potassium |
| Proportion of patients with non-refractory hypertension | 8 weeks after SAAE | Describe how many patients are converted from refractory hypertension to non-refractory hypertension |
Other
| Measure | Time frame | Description |
|---|---|---|
| Daytime average systolic blood pressure | 8 weeks after SAAE | Daytime average systolic blood pressure |
| Daytime average diastolic blood pressure | 8 weeks after SAAE | Daytime average diastolic blood pressure |
| Nighttime average systolic blood pressure | 8 weeks after SAAE | Nighttime average systolic blood pressure |
| Nighttime average diastolic blood pressure | 8 weeks after SAAE | Nighttime average diastolic blood pressure |
Countries
China
Contacts
Primary ContactYifei the second affiliated hospital of Nanchang university, Doctor
Outcome results
None listed