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

NCT02756754 | Completed DMC

• 1 other identifier: 15 7833 08
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Adrenal Adenoma; Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• day-time systolic and diastolic blood pressure

  6 months

• mean 24 hours systolic/diastolic blood pressure

  6 months

• mean day-time ambulatory blood pressure

  6 months

• mean night-time ambulatory blood pressure

  6 months

• mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure

  6 months

Study Arms (1)

Radiofrequency ablation

EXPERIMENTAL

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

Interventions

Radiofrequency ablation DEVICE

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.

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

CHU Bordeaux

Bordeaux, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

• 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.

  PMID: 36380152 RESULT

• 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.

  PMID: 33196558 RESULT

MeSH Terms

Conditions

Hyperaldosteronism; ACTH Syndrome, Ectopic

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Béatrice DULY-BOUHANICK, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 29, 2016
• Study Start: November 7, 2016
• Primary Completion: October 4, 2018
• Study Completion: May 10, 2019
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)