An interventional study of Radiofrequency ablation in Primary Aldosteronism and Adrenal Adenoma, sponsored by University Hospital, Toulouse. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other
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.
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.
193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.
This study's enrollment of 31 is below the median of 60 across 91 interventional studies indexed under Hyperaldosteronism.
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Exclusion Criteria:
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.
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
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
antihypertensive agents
number of antihypertensive agents at 6 months after adrenal radiofrequency ablation
Time frame: 6 months
kalemia
evaluation of kalemia at month 1 and month 6
Time frame: 6 months
CT Scan
description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation
Time frame: 6 months
post-operative complications
post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection
Time frame: 6 months
cost-effectiveness
cost-effectiveness radiofrequency ablation
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse