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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism; Adrenal Adenoma
• Intervention / Treatment: Device: Radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Chu Bordeaux
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiofrequency ablation; 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; 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.

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Béatrice DULY-BOUHANICK, Pr, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimated): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms; Paraneoplastic Syndromes; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Paraneoplastic Endocrine Syndromes; Hyperaldosteronism; ACTH Syndrome, Ectopic; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: 15 7833 08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO