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

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ClinicalTrials.gov Identifier: NCT02756754
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Adrenal Adenoma Device: Radiofrequency ablation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.
Actual Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. antihypertensive agents [ Time Frame: 6 months ]
    number of antihypertensive agents at 6 months after adrenal radiofrequency ablation

  10. kalemia [ Time Frame: 6 months ]
    evaluation of kalemia at month 1 and month 6

  11. CT Scan [ Time Frame: 6 months ]
    description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation

  12. post-operative complications [ Time Frame: 6 months ]
    post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection

  13. cost-effectiveness [ Time Frame: 6 months ]
    cost-effectiveness radiofrequency ablation



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756754


Contacts
Contact: Béatrice DULY-BOUHANICK, Pr 5 61 32 30 84 ext 33 duly-bouhanick.b@chu-toulouse.fr

Locations
France
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Béatrice DULY-BOUHANICK, Pr    5 61 32 30 84 ext 33    duly-bouhanick.b@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Béatrice DULY-BOUHANICK, Pr CHU TOULOUSE

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02756754     History of Changes
Other Study ID Numbers: 15 7833 08
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adenoma
Adrenocortical Adenoma
Hyperaldosteronism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases