Clinical trial · Interventional
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.
NCT02756754CI-TRIAL-00110273ADERADHTAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Adenoma | Adrenal Cortical Adenoma | ALIAS | 0.90 |
| Primary Aldosteronism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation
- description
- 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.
- interventionNames
- Device: Radiofrequency ablation
Primary outcomes (1)
- measure
- mean day-time systolic/diastolic blood pressure
- timeFrame
- 6 months
- description
- 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
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTCosta 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
- RESULTBouhanick 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