Hyperaldosteronism, Idiopathic Hyperaldosteronism
Conditions
Keywords
Superselective adrenal arterial embolization, Spironolactone, Hyperaldosteronism, Hypertension, Mineralocorticoid receptor antagonists(
Brief summary
Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.
Detailed description
Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.
Interventions
Patients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation.
DRUGSpironolactone
Patients will be treated with spironolactone.
Sponsors
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Chengdu Medical College
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from 15 to 60 with no limits in sex; 2. Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines; 3. Sub-typing diagnosis confirmed idiopathic hyperaldosteronism; 4. Patients or their legal representatives have to sign written informed consent approved by the ethics committee.
Exclusion criteria
1. Unilateral adrenal hyperplasia; 2. Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) \<45 ml/min/1.73 m², and/or serum creatinine \>176 μmol/L； 3. Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months; 4. Severe contrast agent allergy; 5. Women who are pregnant or planning to become pregnant; 6. Patients with other serious organic diseases cannot tolerate SAAE treatment; 7. Other forms of secondary hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of 24-h mean systolic blood pressure at 6 months compared with baseline. | 6 months after randomization | change of 24-h mean systolic blood pressure at 6 months compared with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline | 1, 3, 6 months after randomization | Change of office blood pressure at 1, 3, 6 months compared with baseline |
| change of antihypertensive medication burden at 1, 3, 6 months compared with baseline | 1, 3, 6 months after randomization | change of antihypertensive medication burden at 6 months compared with baseline |
| Incidence of clinical events | 6 months after randomization | Incidence of clinical events including: major adverse cardiovascular events(MACE), renal insufficiency, adrenal insufficiency, hyperkalemia, vascular complication, flank/back pain, gynecomastia, breast tenderness, sexual dysfunction,etc. |
| Change of 24-h mean diastolic blood pressure at 6 months compared with baseline. | 6 months after randomization | change of 24-h mean diastolic blood pressure at 6 months compared with baseline. |
| Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline | 3, 6 months after randomization | Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline |
| Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline | 3, 6 months after randomization | Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline |
| Change of Serum potassium at 3, 6 months after randomization, compared with baseline | 3,6 months after randomization | Change of Serum potassium at 3, 6 months compared with baseline |
Countries
China
Contacts
Primary ContactXiongjing Jiang, MD
Backup ContactHui Dong, MD
Outcome results
None listed