Exploratory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
- Conditions
- primary aldosteronism caused by unilateral aldosterone hyper secretion
- Registration Number
- JPRN-UMIN000012792
- Lead Sponsor
- Department of Diagnostic Radiology,Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1. Pasemaker or ICD implantation 2. Possibilities of malignancy 3. impaired blood clotting with PT-INR>=2.0 4. Possibilities of infection 5. Intolerance to acute blood pressure change: a. Abdominal aortic aneurysm with diameter of more than 4cm, Thoracic aortic aneurysm with diameter of more than 5cm, Aortic dissection, Cerebral aneurysm >=5mm b. Impared cardiac function: Transthoracic US: LVEF<40% or E/E'>15 or BNP>200 pg/mL c. hypertensive intracranial bleeding without confirmation of hemostasis (should be confirmed by CT for cerebral bleeding within 180 days) 6.Cushing syndrome or paraganglioma 7. Pregnancy or possibility of pregnancy 8. Hystory of iodine allergy 9. Participants of other clinical trial 10. Difficulty in cessation of the drugs which are prohibited in this trial 11. Patients who are judged as in adequate for this trial by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aldosterone level in serum and 24-hour urine collection 7 days after ablation therapy
- Secondary Outcome Measures
Name Time Method 1. Clinical laboratory test ACTH, cortisol, serum aldosterone, renin activity, ARR, serum TTKG, osmotic pressure and pottasium level, urine osmolality 2. Antihypertensive medication Dose at screening and 84 days after ablation therapy 3. Ablation effect evaluation by enhanced computed tomography 7 days after treatment.