The Effect of SAAE on Ventricular Remodeling in PA Patients

Study Overview
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Brief Summary
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The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.

Detailed Description
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After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.

Official Title
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The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism： A Randomized Controlled Clinical Study

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Other: Super selective adrenal artery embolization
* Drug: Spironolactone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Age 18-60 years old, regardless of gender; (2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling; (4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization; (5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening. Exclusion Criteria: (1) Primary hypertension or secondary hypertension with other causes; (2) A woman who is pregnant or lactating, or has a birth plan for the next year; (3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR<45 mL/min/1.73 m2); (4) Severe allergy to contrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6) Adrenal CT showed adenoma.; (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAAE group<br>Subjects received super selective adrenal artery embolization treatment | Other: Super selective adrenal artery embolization<br>* 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.<br>|
| Active Comparator: Spironolactone group<br>Subjects received spironolactone treatment | Drug: Spironolactone<br>* Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVMI | Left ventricular mass index(LVMI) | 12 months after SAAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVH | left ventricular hypertrophy | 12 months after SAAE | 
| ABPM | 24-hour ambulatory blood pressure monitor | 1 month after SAAE | 
| ABPM | 24-hour ambulatory blood pressure monitor | 12 months after SAAE | 
| PAC | plasma aldosterone concentration | 1 month after SAAE | 
| PAC | plasma aldosterone concentration | 12 months after SAAE | 
| PRA | plasma renin activity | 1 month after SAAE | 
| PRA | plasma renin activity | 12 months after SAAE | 
| ARR | aldosterone-to-renin ratio | 1 month after SAAE | 
| ARR | aldosterone-to-renin ratio | 12 months after SAAE | 
| Serum potassium | Serum potassium | 1 month after SAAE | 
| Serum potassium | Serum potassium | 12 months after SAAE | 
| serum creatinine | serum creatinine | 1 month after SAAE | 
| serum creatinine | serum creatinine | 12 months after SAAE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary aldosteronism, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling