Primary Aldosteronism
Conditions
Keywords
primary aldosteronism, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling
Brief summary
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
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.
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.
DRUGSpironolactone
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVMI | 12 months after SAAE | Left ventricular mass index(LVMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PRA | 1 month after SAAE | plasma renin activity |
| ARR | 1 month after SAAE | aldosterone-to-renin ratio |
| Serum potassium | 1 month after SAAE | Serum potassium |
| PAC | 1 month after SAAE | plasma aldosterone concentration |
| LVH | 12 months after SAAE | left ventricular hypertrophy |
| ABPM | 1 month after SAAE | 24-hour ambulatory blood pressure monitor |
| serum creatinine | 1 month after SAAE | serum creatinine |
Countries
China
Contacts
Primary ContactYifei Dong, Doctorate
Outcome results
None listed