JPRN-jRCT2022200042
Completed
未知
Exploratory clinical trial to evaluate safety and efficacy of transvenous radiofrequency ablation for primary aldosteronism patients
Takase Kei0 sites5 target enrollmentMarch 26, 2021
Conditionseft aldosterone producing adenoma.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- eft aldosterone producing adenoma.
- Sponsor
- Takase Kei
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Males and females who are adults (20 years old or older) at the time of obtaining consent
- •(2\) Patients who agree to participate clinical trial on document
- •(3\) Patients with primary aldosteronism (within 365 days after confirmed diagnosis) who meet the following conditions with lower risk of complications of proximal organs
- •1\) There are more than 5mm interventional adipose tissue between adrenal adenoma and pancreas or intestinal tract
- •2\) The expected site of aldosterone overproduction or aldosterone\-producing adenoma must be less than 15mm in minor axis longitude
- •3\) Diagnosed left unilateral lesion in adrenal venous sampling and proved the expected place in which overproduces aldosterone focally in adrenal gland
- •The diagnose of unilateral is done in accordance with Consensus statement on the treatment of primary aldosteronism in our country in 2016\. (However, we exclude cases in which the contralateral adrenal gland is dysfunctional, or the cortisol\-secreting capacity of the contralateral adrenal gland is severely reduced. We also exclude cases after contralateral adrenalectomy.)
- •If you want to learn the details of the standard to diagnose , you should refer \<5\.1Standards of the judgement of unilateral\>
- •(4\) Patients who meet the following standards in screening and whose major organs functions are preserved
- •1\) The number of white blood cells is \>\= 3000/mm3
Exclusion Criteria
- •(1\) Patients with pacemakers or implantable cardioverter defibrillators
- •(2\) Patients who have a possibility of malignant adrenal tumor
- •(3\) Patients with bleeding tendency or who are unable to stop taking medications which promote bleeding tendency (PT\-INR \>\= 2\.0\)
- •(4\) Patients with previous adrenal gland surgery or ablation
- •(5\) Patients deep vein thrombosis within 30 days after obtaining consent
- •(6\) Patients with signs or symptoms of infection
- •(7\) Patients with potential for serious events if they experience rapid blood pressure changes
- •1\) Patients with any of the following known diseases : abdominal aortic aneurysm with a maximum short diameter of 4 cm or greater, thoracic aortic aneurysm with a maximum short diameter of 5 cm or greater, aortic dissection or unruptured cerebral aneurysm with a diameter of 5 mm or more
- •2\) Patients who meet any of the following criteria for cardiac function in transthoracic echocardiography : LVEF \<\= 40%, E/E' \>\= 15 or BNP \>\= 200 pg/mL
- •3\) Patients with hypertensive cerebral hemorrhage with unconfirmed hemostasis
Outcomes
Primary Outcomes
Not specified
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