Clinical trial NCT02756754: Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism
Official title: Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism
Adrenal Adenoma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: mean day-time systolic/diastolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: day-time systolic and diastolic blood pressure
timeFrame: 6 months
measure: mean 24 hours systolic/diastolic blood pressure
timeFrame: 6 months
measure: mean day-time ambulatory blood pressure
timeFrame: 6 months
measure: mean night-time ambulatory blood pressure
timeFrame: 6 months
measure: mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure
timeFrame: 6 months
measure: casual systolic blood pressure / diastolic blood pressure
timeFrame: 6 months
measure: decrease of casual systolic blood pressure
timeFrame: 6 months
measure: mean daytime ambulatory blood pressure changes assessed by self-measurement
timeFrame: 6 months
measure: antihypertensive agents
timeFrame: 6 months
measure: kalemia
timeFrame: 6 months
measure: CT Scan
timeFrame: 6 months
measure: post-operative complications
timeFrame: 6 months
measure: cost-effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU Toulouse
name: Béatrice DULY-BOUHANICK, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa N, Mounie M, Gombault-Datzenko E, Boulestreau R, Cremer A, Delchier MC, Gosse P, Lagarde S, Lepage B, Molinier L, Papadopoulos P, Trillaud H, Rousseau H, Bouhanick B. Cost Analysis of Radiofrequency Ablation for Adrenal Adenoma in Patients with Primary Aldosteronism and Hypertension: Results from the ADERADHTA Pilot Study and Comparison with Surgical Adrenalectomy. Cardiovasc Intervent Radiol. 2023 Jan;46(1):89-97. doi: 10.1007/s00270-022-03295-9. Epub 2022 Nov 15.