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Completed

NCT Number: NCT02756754

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency Ablation

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ADERADHTA

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 29, 2016
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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