Transvenous RFA for primary aldosteronism

JRCT ID: jRCT2022200042

Registered date:26/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Left aldosterone producing adenoma.
• Date of first enrollment: 17/08/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): The left aldosterone producing adenoma causing primary aldosteronism is ablated with radiofrequency to nomalize aldosterone secretion. The lesion is ablated by a flexible cautery catheter through a guiding sheath inserted into the adrenal vein via the femoral vein.

Outcome(s)

• Primary Outcome: The number of subjects whose plasma aldosterone concentration 4(+1) days after clinical trial treatments was lower than baseline (values on the day of the clinical trial treatments)

Secondary Outcome

1) Clinical items
Blood pressure and the number of hypertension medicines 4(+1)day, 28(+-7)day and 84(+-7)day after clinical trial treatments (as defined daily dose : DDD)
2) Biochemical items
plasma aldosterone concentration 1 day, 2 day, 3 day, 4(+1) day, 28(+-7) day and 84(+-7) day after clinical trial treatments
Active renin concentration : ARS, ARR and serum potassium level 4(+1) day, 28(+-7) day and 84(+-7) day after clinical trial treatments
3) Effects of ablation of overproduction sites on contrast-enhanced CT 4(+1) day after clinical trial treatments
4) Equipment evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.)
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(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

Exclude 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
(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.

Related Information

• Primary Sponsor: Takase Kei
• Source(s) of Monetary Support: Japan Agency for Medhical Research and Development,Japan Lifeline