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New heat therapy could replace surgery for Hormone-Fueled hypertension

NCT ID NCT07470580

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Hospital of Toulouse

    RECRUITING

    Toulouse, France

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