Primary aldosteronism
Conditions
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, male or female; 2. Able to understand the study objectives and procedures, willing to participate voluntarily, and able to provide written informed consent; 3. Meets the diagnostic criteria for primary aldosteronism (PA) according to the Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2024 Edition) and has completed standardized diagnostic evaluation; 4. Adrenal CT indicates bilateral hyperplasia, bilateral nodules, or bilateral adenomas (including unilateral adenoma with contralateral hyperplasia), or the patient is clinically classified as idiopathic hyperaldosteronism (IHA) or bilateral primary aldosteronism (BPA); 5. Evidence of dominant aldosterone secretion on one side is present and meets at least one of the following conditions: (1) AVS indicates a clear dominant side of aldosterone secretion: regardless of whether ACTH stimulation is used, a lateralization index (LI) >=4.0; for patients with an LI between 2.0 and 4.0, those may also be included if multidisciplinary discussion reaches consensus that dominant aldosterone secretion is present; (2) Molecular imaging (68Ga-Pentixafor PET/CT or 11C-Metomidate PET/CT) indicates a clear dominant side of aldosterone secretion: positive visual assessment or dominant-side SUVmax/non-dominant-side SUVmax (LI) >1.5; 6. Imaging demonstrates an adrenal lesion corresponding to the side of dominant aldosterone secretion; 7. Preoperative electrolyte disturbances have been corrected to a perioperatively acceptable level; 8.Blood pressure has been adjusted with medication to an acceptable range for the procedure before treatment (mean seated office systolic blood pressure <180 mmHg and diastolic blood pressure <110 mmHg); 9. Willing to complete postoperative follow-up according to the study protocol.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from enrollment: 1. Unilateral aldosterone-producing adenoma with a normal contralateral adrenal gland in terms of morphology and size; 2. Lack of sufficient evidence of dominant aldosterone secretion on one side, or unclear lateralization; 3. Adrenal lesion diameter >=3 cm; 4. Suspected adrenal malignancy, metastatic tumor, or other lesions unsuitable for local ablation; 5. Concomitant overt autonomous cortisol secretion, Cushing’s syndrome, pheochromocytoma, or other functional adrenal disorders that have not been excluded; 6. Severe coagulation dysfunction or uncorrectable bleeding tendency; 7. Severe cardiac, pulmonary, hepatic, or renal insufficiency rendering the patient unable to tolerate the interventional procedure; 8. Active infection or poorly controlled systemic infection; 9. Pregnant or breastfeeding women, or women planning pregnancy during the study period; 10. Severe allergy to contrast agents, anesthetic agents, perioperative medications, or related devices that cannot be adequately pretreated; 11. Prior surgery or ablation of the ipsilateral adrenal gland that may interfere with efficacy assessment; 12. Lesions adjacent to critical structures such that complete ablation cannot be safely performed in the investigator’s judgment; 13. Severe psychiatric illness, cognitive impairment, or poor compliance that would prevent cooperation with the investigators; 14. Participation in another interventional clinical study within the past 3 months; 15. Any other condition that, in the investigator’s judgment, makes the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete biochemical remission rate at 6 months after ablation;Partial biochemical success rate at 6 months after ablation;Incidence of major adverse events from the intraoperative period to 30 days after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum aldosterone;Renin;Aldosterone/renin ratio, ARR;Serum potassium;Blood pressure;Types and doses of antihypertensive drugs;Renal function; | — |
Countries
China
Contacts
Public ContactMing Liu
Tianjin Medical University General Hospital
Outcome results
None listed