Primary AldosteronismADERADHTANCT02756754
Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism
A study testing Radiofrequency ablation in people with Primary Aldosteronism and Adrenal Adenoma, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism, Adrenal Adenoma
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Nov 2016to 10 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- coagulopathy
- pregnant women
- patient with potentially inaccessible nodule
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Aldosteronism, Adrenal Adenoma
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Hyperaldosteronism, ACTH Syndrome, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | 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. Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean day-time systolic/diastolic blood pressure
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
Measured: 6 months
Secondary outcomes (13)
day-time systolic and diastolic blood pressure
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
Measured: 6 months
mean 24 hours systolic/diastolic blood pressure
mean 24 hours systolic/diastolic blood pressure <130/80 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment
Measured: 6 months
mean day-time ambulatory blood pressure
mean day-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months
Measured: 6 months
mean night-time ambulatory blood pressure
mean night-time ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months
Measured: 6 months
mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure
mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure monitoring between baseline and 6 months
Measured: 6 months
casual systolic blood pressure / diastolic blood pressure
casual systolic blood pressure / diastolic blood pressure <140/90 mmHg after adrenal radiofrequency ablation, at six months without antihypertensive treatment
Measured: 6 months
decrease of casual systolic blood pressure
decrease of casual systolic blood pressure of 20 mmHg and of casual diastolic blood pressure of 10 mmHg between baseline and 6 months
Measured: 6 months
mean daytime ambulatory blood pressure changes assessed by self-measurement
mean daytime ambulatory blood pressure changes assessed by self-measurement of blood pressure monitoring between baseline and 6 months
Measured: 6 months
antihypertensive agents
number of antihypertensive agents at 6 months after adrenal radiofrequency ablation
Measured: 6 months
kalemia
evaluation of kalemia at month 1 and month 6
Measured: 6 months
CT Scan
description of the CT scan aspect of the adrenal gland after adrenal radiofrequency ablation
Measured: 6 months
post-operative complications
post-operative complications including retroperitoneal hematoma, pneumothorax, pain, infection
Measured: 6 months
cost-effectiveness
cost-effectiveness radiofrequency ablation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start7 Nov 2016
- Primary completion4 Oct 2018
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice DULY-BOUHANICK, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756754
- Sponsor's protocol ID
- 15 7833 08
- Acronym
- ADERADHTA
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2016
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Costa N, Mounie M, Gombault-Datzenko E, Boulestreau R, Cremer A, Delchier MC, Gosse P, Lagarde S, Lepage B, Molinier L, Papadopoulos P, Trillaud H, Rousseau H, Bouhanick B. Cost Analysis of Radiofrequency Ablation for Adrenal Adenoma in Patients with Primary Aldosteronism and Hypertension: Results from the ADERADHTA Pilot Study and Comparison with Surgical Adrenalectomy. Cardiovasc Intervent Radiol. 2023 Jan;46(1):89-97. doi: 10.1007/s00270-022-03295-9. Epub 2022 Nov 15.
PubMed 36380152Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708.
PubMed 33196558
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.
- ClinicalTrials.gov ID
- NCT02756754
- Acronym / sponsor ID
- ADERADHTA / 15 7833 08
- Conditions
- Primary Aldosteronism, Adrenal Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Device: Radiofrequency ablationRadiofrequency 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationThe 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 |
Primary outcome
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
13 secondary outcomes
day-time systolic and diastolic blood pressure
Time frame: 6 months
mean 24 hours systolic/diastolic blood pressure
Time frame: 6 months
mean day-time ambulatory blood pressure
Time frame: 6 months
mean night-time ambulatory blood pressure
Time frame: 6 months
mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure
Time frame: 6 months
casual systolic blood pressure / diastolic blood pressure
Time frame: 6 months
decrease of casual systolic blood pressure
Time frame: 6 months
mean daytime ambulatory blood pressure changes assessed by self-measurement
Time frame: 6 months
antihypertensive agents
Time frame: 6 months
kalemia
Time frame: 6 months
CT Scan
Time frame: 6 months
post-operative complications
Time frame: 6 months
cost-effectiveness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 36380152Costa N, Mounie M, Gombault-Datzenko E, Boulestreau R, Cremer A, Delchier MC, Gosse P, Lagarde S, Lepage B, Molinier L, Papadopoulos P, Trillaud H, Rousseau H, Bouhanick B. Cost Analysis of Radiofrequency Ablation for Adrenal Adenoma in Patients with Primary Aldosteronism and Hypertension: Results from the ADERADHTA Pilot Study and Comparison with Surgical Adrenalectomy. Cardiovasc Intervent Radiol. 2023 Jan;46(1):89-97. doi: 10.1007/s00270-022-03295-9. Epub 2022 Nov 15.
- Results publication: PubMed 33196558Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice DULY-BOUHANICK, Pr principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Primary Aldosteronism and Adrenal Adenoma, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean day-time systolic/diastolic blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.