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

July 15, 2019 updated by: University Hospital, Toulouse

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.

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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months
6 months
antihypertensive agents
Time Frame: 6 months
number of antihypertensive agents at 6 months after adrenal radiofrequency ablation
6 months
kalemia
Time Frame: 6 months
evaluation of kalemia at month 1 and month 6
6 months
CT Scan
Time Frame: 6 months
description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation
6 months
post-operative complications
Time Frame: 6 months
post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection
6 months
cost-effectiveness
Time Frame: 6 months
cost-effectiveness radiofrequency ablation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Béatrice DULY-BOUHANICK, Pr, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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