Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism (NCT02756754) | Clinical Trial Compass
CompletedNot Applicable
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism
France31 participantsStarted 2016-11-07
Plain-language summary
The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* hypertension confirmed with ambulatory blood pressure monitoring
* primary aldosteronism demonstrated by hormonal assays: active renin (pg/ml) or plasma renin activity (ng/ml/h) and plasma aldosterone measured twice at baseline after an overnight fast, in sitting or recumbent position
* selective adrenal venous sampling after 40 years of age
* unilateral adrenal nod on CT scan \<4cm
* adrenal radiofrequency ablation procedure of judged technically possible by radiologists
Exclusion Criteria:
* bilateral adrenal nods
* primary aldosteronism due to bilateral adrenal hyperplasia or macronodular hyperplasia
* lack of documented primary aldosteronism
* maximum tumor diameter greater than 4 cm
* Cushing syndrome or Pheochromocytoma
* when adrenal venous sampling is refused by the patient
* coagulopathy
* pregnant women
* patient with potentially inaccessible nodule