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 imaging (CT or MRI) suggests unilateral PA and meets at least one of the following conditions: (1) Meets the criteria for AVS exemption: spontaneous hypokalemia (serum potassium =20 ng/dL by immunoassay or >=15 ng/dL by mass spectrometry), suppressed renin (=10 mm), and a normal contralateral adrenal gland (without obvious thickening or nodules); (2) AVS indicates lateralized aldosterone secretion on the adenoma side: 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; (3) Molecular imaging (68Ga-Pentixafor PET/CT or 11C-Metomidate PET/CT) indicates dominant aldosterone secretion from a unilateral adenoma: positive visual assessment or dominant-side SUVmax/non-dominant-side SUVmax (LI) >1.5; 5. Preoperative electrolyte disturbances have been corrected to a perioperatively acceptable level; 6. 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); 7. 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. Lack of sufficient evidence for unilateral primary aldosteronism (PA), or imaging findings suggestive of bilateral adrenal disease, bilateral adenomas, or bilateral adrenal nodules; 2. Adrenal lesion diameter >=3 cm; 3. Suspected adrenal malignancy, metastatic tumor, or other lesions unsuitable for local ablation; 4. Concomitant overt autonomous cortisol secretion, Cushing’s syndrome, pheochromocytoma, or other functional adrenal disorders that have not been excluded; 5. Severe coagulation dysfunction or uncorrectable bleeding tendency; 6. Severe cardiac, pulmonary, hepatic, or renal insufficiency rendering the patient unable to tolerate the interventional procedure; 7. Active infection or poorly controlled systemic infection; 8. Pregnant or breastfeeding women, or women planning pregnancy during the study period; 9. Severe allergy to contrast agents, anesthetic agents, perioperative medications, or related devices that cannot be adequately pretreated; 10. Prior surgery or ablation of the ipsilateral adrenal gland that may interfere with efficacy assessment; 11. Lesions adjacent to critical structures such that complete ablation cannot be safely performed in the investigator’s judgment; 12. Severe psychiatric illness, cognitive impairment, or poor compliance that would prevent cooperation with the investigators; 13. Participation in another interventional clinical study within the past 3 months; 14. 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-to-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