Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study (SAAE-BIH)
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|ClinicalTrials.gov Identifier: NCT05186675|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)||Procedure: superselective adrenal arterial embolization||Not Applicable|
Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for more than 5% of the general hypertensive cases and 17-20% of resistant hypertension.The most common PA subtype is bilateral idiopathic hyperaldosteronism (IHA), and medical therapy with mineralocorticoid receptor antagonists (MRAs) is recommended for these patients.The clinical studies showed that PA patients had more cardiovascular events than patients with essential hypertension independent of blood pressure, and PA patients with higher plasma aldosterone levels had a higher cardiovascular risk. However, MRAs are unable to reduce the level of plasma aldosterone. Moreover, the undesirable adverse effects of MRAs also limit their wide application, particularly in men.
Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study|
|Estimated Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Superselective adrenal arterial embolization
For patients with bilateral idiopathic hyperaldosteronism confirmed by adrenal venous sampling, Superselective adrenal arterial embolization（SAAE）shall be given according to the patient's wishes. The blood pressure, plasma aldosterone and potassium levels, and adverse events were assessed after SAAE. The primary endpoint was the change in home blood pressure at one months, compared with baseline.
Procedure: superselective adrenal arterial embolization
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
- Ambulatory blood pressure monitoring [ Time Frame: one month after SAAE ]24-hour ambulatory blood pressure monitor
- Office blood pressure [ Time Frame: one month after SAAE ]sphygmomanometer
- plasma aldosterone [ Time Frame: one month after SAAE ]reagent
- potassium levels [ Time Frame: one month after SAAE ]reagent
- adverse events [ Time Frame: one month after SAAE ]follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186675
|Contact: Xiong Hongliang, Masteremail@example.com|
|Study Director:||Dong Yifei, Doctor||Second Affiliated Hospital of Nanchang University|