confirmatory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)

confirmatory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial) - confirmatory trial of radiofrequency ablation therapy for primary aldosteronism patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015865

Enrollment

Registered

2014-12-08

Start date

2014-12-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary aldosteronism caused by unilateral aldosterone hyper secretion

Interventions

CT guided radiofrequency ablation is performed with total power of 4-6kJ for aldosterone producing adrenal adenoma which is proven as unilateral functioning adenoma by adrenal venous sampling.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Equal or more than 20 years old at the time of informed concent. 2. Agreement with written informed concent. 3. Primary aldosteronism with unilateral functioning macroadenoma with following conditions: a. CT detectable adenoma without any risky organs on a puncture route. b. Intervening adipose tissue between target adenoma and adjacent risky organs(pancreas or intestine). c. Adenoma diameter between 5 and 25mm. d. Unilateral single functioning macroadenoma with aldosterone hypersecretion proven by adrenal venous sampling. e. Enough major organic function with following labolatory datas at screening: WBC>=3000/mm3 Plt>=100,000/mm3, Hb>=8.0 g/dl,eGFR>=45mL/min/1.73m2 f. PS=0-2

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
aldosterone normalization rate based on serum aldosterone consentration and alrosterone/renin ratio 7 days after ablation therapy	—

Secondary

Measure	Time frame
1. Clinical laboratory test serum aldosterone, renin activity, Na,K, urine Na,K, ARR, TTKG, osmotic pressure and pottasium level, eGFR 2. Antihypertensive medication Dose at screening and 3,7,28,and 84 days after ablation therapy 3. Ablation effect evaluation by enhanced computed tomography 7 days after treatment.	—

Countries

Japan

Contacts

Public ContactKei Takase

Tohoku University Hospital Department of Diagnostic Radiology

ktakase@rad.med.tohoku.ac.jp0227177312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026