Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The prevalence of hypertension dramatically increased. Although most cases of hypertension are idiopathic, some cases have an identifiable cause. Primary Aldosteronism (PA) is the most common cause of secondary hypertension and can be cured by surgery if PA is due to unilateral unique adrenal adenoma. Then this cause is worth identifying it. The surgery despite its minimally invasive nature is limited by the need for general anesthesia, the risk of vascular or visceral injuries, hematomas and all the adrenal gland is mostly removed. Imaged-guided percutaneous adrenal radiofrequency ablation (ARF) offers a less invasive alternative therapeutic option. This local therapy is employed to treat solid neoplasms whereas its application on functional adrenal adenoma is less documented and only a few case series with limited sample size are published. The impact on blood pressure control is not clearly reported. ARF ablation works by delivering a high-frequency alternating current through a needle electrode. An ionic agitation occurs and generates frictional heat for cell destruction at a predictable temperature and volume. Patients with a conventional documented PA due to unilateral adrenal nod who consented to the study were hospitalized. Patients with PA due to an aldosterone-producing adenoma are included in the study.

Official Title
-----------------
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.

Conditions
-----------------
Primary Aldosteronism, Adrenal Adenoma

Intervention / Treatment
-----------------
* Device: Radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation<br>Radiofrequency ablation (RFA) is a minimally invasive technique for eliminating both primary tumors and metastases. The needles that will be used are monopolar RFA, the LeVeen™ Needle Electrode Family with a generator RF 3000 by Boston Scientific. The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored. | Device: Radiofrequency ablation<br>* The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean day-time systolic/diastolic blood pressure | mean day-time systolic/diastolic blood pressure <135/85 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment or a decrease of daytime systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day-time systolic and diastolic blood pressure | To assess a decrease of day-time systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months | 
| mean 24 hours systolic/diastolic blood pressure | mean 24 hours systolic/diastolic blood pressure <130/80 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment | 6 months | 
| mean day-time ambulatory blood pressure | mean day-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months | 
| mean night-time ambulatory blood pressure | mean night-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months | 
| mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure | mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months | 6 months | 
| casual systolic blood pressure / diastolic blood pressure | casual systolic blood pressure / diastolic blood pressure <140/90 mmHg after adrenal radiofrequency ablation, at six months without antihypertensive treatment | 6 months | 
| decrease of casual systolic blood pressure | decrease of casual systolic blood pressure of 20 mmHg and of casual diastolic blood pressure of 10 mmHg between baseline and 6 months | 6 months | 
| mean daytime ambulatory blood pressure changes assessed by self-measurement | mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months | 6 months | 
| antihypertensive agents | number of antihypertensive agents at 6 months after adrenal radiofrequency ablation | 6 months | 
| kalemia | evaluation of kalemia at month 1 and month 6 | 6 months | 
| CT Scan | description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation | 6 months | 
| post-operative complications | post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection | 6 months | 
| cost-effectiveness | cost-effectiveness radiofrequency ablation | 6 months |