- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756754
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism (ADERADHTA)
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
-
Toulouse, France, 31059
- Chu de Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Béatrice DULY-BOUHANICK, Pr, CHU Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Adrenocortical Hyperfunction
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Adenoma
- Hyperaldosteronism
- Adrenocortical Adenoma
Other Study ID Numbers
- 15 7833 08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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