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

Primary Aldosteronism Clinical Trial

— ADERADHTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756754
• Other study ID #: 15 7833 08
• Status: Completed
• Phase: N/A
• Start date: November 7, 2016
• Est. completion date: May 10, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 10, 2019
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adrenal Adenoma
• Adrenocortical Adenoma
• Hyperaldosteronism
• Primary Aldosteronism

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	antihypertensive agents	number of antihypertensive agents at 6 months after adrenal radiofrequency ablation	6 months
Secondary	kalemia	evaluation of kalemia at month 1 and month 6	6 months
Secondary	CT Scan	description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation	6 months
Secondary	post-operative complications	post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection	6 months
Secondary	cost-effectiveness	cost-effectiveness radiofrequency ablation	6 months