Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism
Recruiting · NCT07328230 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
View the official record on ClinicalTrials.gov →Interventions studied
SpironolactoneSuperselective Adrenal Arterial Embolization
What this trial is about
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.
Who can take part
Age range
15 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Aged from 15 to 60 with no limits in sex;
- Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
- Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
- Patients or their legal representatives have to sign written informed consent approved by the ethics committee.
Exclusion criteria
- Unilateral adrenal hyperplasia;
- 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；
- Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
- Severe contrast agent allergy;
- Women who are pregnant or planning to become pregnant;
- Patients with other serious organic diseases cannot tolerate SAAE treatment;
- Other forms of secondary hypertension.
Where it is running
3 locations listed.
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College - Beijing, Beijing Municipality, China
- Second Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Affiliated Hospital of Chengdu Medical College - Chengdu, Sichuan, China