New heat therapy could replace surgery for Hormone-Fueled hypertension
NCT ID NCT07470580
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two treatments for a condition called primary aldosteronism, where a small adrenal gland tumor causes high blood pressure. One treatment is laparoscopic surgery to remove the tumor; the other is radiofrequency ablation (RFA), which uses heat delivered through a needle to destroy the tumor. The goal is to see if RFA works as well as surgery to normalize blood pressure and hormone levels, with fewer side effects. About 134 adults with a confirmed adrenal adenoma will be randomly assigned to one of the two procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiofrequency ablation (RFA) procedure
- What this could lead to
- If RFA works as well as surgery, patients could avoid an operation and have a quicker recovery with fewer complications.
- What could go wrong
- This is a relatively new use of RFA for this condition, and it may not be as effective as surgery in the long term. The trial is still recruiting, so results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient over 18 years of age * Hypertension confirmed into the previous 9 months by ABPM 24h SBP/DBP \>130 and/or/80 mmHg and/or diurnal SBP/DBP \> 135 and/or 85 mmHg and/or nocturnal SBP/DBP \>120 and/or 70 mmHg with or without antihypertensive treatment * Diagnosis of primary aldosteronism confirmed by hormonal assays no more than 1 year before inclusion * Presence of a unilateral adrenal nodule \<4 cm considered suggestive of a Conn's adenoma on an prior adrenal CT or MRI scan, no more than 1 year before inclusion * Adrenal venous sampling if age \> 35 years (and according to investigator decision if age \<35 years) to look for a lateralization of secretion: cannulation was successful when adrenal/peripheral venous cortisol gradients\>2 and lateralization was assessed by comparison of right and left adrenal venous aldosterone/cortisol ratios with a cut off value\>4 ipsilateral to the nod side to define a positive lateralization of secretion (2) no more than 1 year before inclusion * nodule accessible to RFA according to the judgement of the interventional radiologist performing radiofrequency before randomisation * nodule accessible to surgery * patient willing to return for 6-month follow-up * adult patient able to read the information sheet and give consent to take part in the study * Patients affiliated to the French Health Insurance Exclusion Criteria: * a negative lateralization of secretion on adrenal venous sampling * presence of bilateral adrenal tumours * contralateral or bilateral macronodular adrenal hyperplasia * no documented primary aldosteronism * Cushing's syndrome or pheochromocytoma * adrenal tumour \> 4 cm * refusal to perform adrenal catheterisation if age \> 35 years * double anti-platelet aggregation, coagulation disorders or patients treated with anticoagulant treatment that cannot be stopped * contraindication to anaesthesia * excessive proximity to sensitive adjacent organs * patient who has had a heart attack or stroke within the last 6 months * allergy to iodine * renal insufficiency defined as a clearance of \<30 ml/min * refusal to undergo radiofrequency ablation or adrenal surgery * minors and patients under guardianship, curatorship or safeguard of justice * Inability to speak, read or write French fluently * patients who refuse follow-up * pregnant women or women wishing to become pregnant in the short term; breast-feeding * person taking part or having taken part in other interventional research in the previous 6 months * any other relevant exclusion criteria as determined by the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital of Toulouse
RECRUITINGToulouse, France
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