JPRN-jRCT2022200042已完成未知
Exploratory clinical trial to evaluate safety and efficacy of transvenous radiofrequency ablation for primary aldosteronism patients
Takase Kei0 个研究点目标入组 5 人开始时间: 2021年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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
- •2) The number of platelets is >= 100,000/mm3
- •3) Hb >= 8.0 g/dl
- •4) eGFR >= 45 mL/min/1.73m2
- •5) Patient whose Performance Status (PS) is 0 - 2 at registration
排除标准
- •(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
- •(When the patient has history of cerebral hemorrhage within 180 days, check on CT)
- •(8) Patients with Cushings syndrome or pheochromocytoma
- •(9) Patients who are or might be pregnant
- •(10) Patients with a history of adverse reactions to iodine contrast
- •(11) Patients participating in another clinical trial or clinical study with intervention at the time of enrollment
- •(12) Patients who have difficulty discontinuing device therapy and surgical therapy for the treatment of primary aldosteronism
- •(13) In addition, patients who were judged unsuitable by the principal investigator or sub-investigator
- •The following criteria can be used to rule out endocrine disorders other than primary aldosteronism (Cushing's syndrome, pheochromocytoma). However, other test results are also comprehensively evaluated to make a definitive diagnosis.
- •Cushing's syndrome
- •Serum cortisol level is less than 1.8 ug/dl in 1 mg dexamethasone suppression test (overnight method).
- •pheochromocytoma
- •Urinary metanephrines and normetanephrines (creatinine corrected) at any time are less than three times the upper limit of normal.
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