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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: To assess whether blood pressure response is improved after adrenal radiofrequency ablation in hypertensive patients with primary aldosteronism and an aldosterone producing adenoma reflected [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome:

• 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 <130/80 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment [ Time Frame: 6 months ]
• mean day-time, night-time and 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 <140/90 mmHg after adrenal radiofrequency ablation, at six months without antihypertensive treatment [ 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 [ Time Frame: 6 months ]
• mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months [ Time Frame: 6 months ]
• number of antihypertensive agents at 6 months after adrenal radiofrequency ablation [ Time Frame: 6 months ]
• evaluation of kalemia at month 1 and month 6 [ Time Frame: 6 months ]
• description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation [ Time Frame: 6 months ]
• post-operative complications including [ Time Frame: 6 months ]
  retroperitoneal hematoma, pneumothorax, pain, infection
• cost-effectiveness radiofrequency ablation [ Time Frame: 6 months ]

Information By: University Hospital, Toulouse

Dates:
Date Received: April 26, 2016
Date Started: September 2016
Date Completion: August 2018
Last Updated: August 16, 2016
Last Verified: August 2016