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Compares treatment options for Primary Aldosteronism Due to Conn Adenoma
Official title Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
ClinicalTrials.gov ID: NCT07470580
What this study is testing
- What it's testing
- Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Adrenal venous sampling if age \> 35 years (and according to investigator decision if age \ 2 and lateralization was assessed by comparison of right...
You likely can't join if
- 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
See the full eligibility 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...
- 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 \ 2 and lateralization was assessed by comparison of right and left adrenal venous aldosterone/cortisol ratios with a cut off...
- nodule accessible to RFA according to the judgement of the treatment 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
- 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 treatment research in the previous 6 months
- any other relevant exclusion criteria as determined by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.