Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%.
More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma.
Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
a negative lateralization of secretion on adrenal venous sampling
presence of bilateral adrenal tumours
contralateral or bilateral macronodular adrenal hyperplasia
no documented primary aldosteronism
Trial design
Design model
Parallel
Treatments tested in this trial
RFA -radiofrequency ablation
Procedure/SurgeryUnder real-time multidetector CT-guidance, the patients will be put in either prone or lateral decubitus position to choose for the optimal access route for RFA needle electrode. Under multidetector CT guidance, patients would be treated with regard to optimal RFA needle access route with a hydrodissection or aero dissection if necessary. 2 types of generator (Boston Scientific RF 3000, and Ablatech Amica) and of needle electrodes (Leveen-type extendable, Ablatech) will be used according to the routine care of the centers
Adrenalectomy
Procedure/SurgeryAdrenalectomy may be performed using a laparoscopic or open approach. In either approach, the gland may be approached transabdominally or retroperitoneally. The choice of surgical approach depends on the size and nature of the lesion, the patient's general characteristics and the expertise of the surgeon. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Patient treated by RFA -radiofrequency ablationExperimental treatment 1 intervention
Group B: Patients treated by adrenalectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
aldosterone-to-renin ratio (ARR) after 15min in the sitting position
aldosterone-to-renin ratio (ARR) after 15 min in the sitting position. Following the recommendations given by Douillard et al (15), normalisation of the ARR will be defined (according to the measurement method) using: * a cut-off value of the ARR of 23 (plasma aldosterone in pg/mL and direct renin in mIU/l) or 64 (plasma aldosterone in pmol/L and direct renin in mIU/l) * a cut-off value of the ARR of 300 (plasma aldosterone in pg/mL and PRA in ng/mL/h), or 830 (plasma aldosterone in pmol/L and PRA in ng/mL/h), or 25 (plasma aldosterone in pg/mL and PRA in pmol/L/min), or 70 (plasma aldosterone in pmol/l and PRA in pmol/L/min). (8,15) * a cut-off value of the ARR of 46 (plasma aldosterone in pmol/l in Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and renin in mU/l) (16)
Time frame
3 monthsSecondary outcomes
1
Clinical success at 3 months
Clinical success, defined according to PASO outcome definitions at 3 months of follow-up, assessed by ambulotary blood pressure monitoring : * Complete clinical success: normal blood pressure without the aid of antihypertensive medication Partial clinical success: same blood pressure as before intervention†, with less antihypertensive medication‡ or a reduction in blood pressure with either the same amount or less antihypertensive medication * Absent clinical success: unchanged or increased blood pressure† with either the same amount or an increase in antihypertensive medication
Time frame
3 months2
Clinical success at 6 months
Clinical success, defined according to PASO outcome definitions at 6 months of follow-up, assessed by ambulotary blood pressure monitoring : * Complete clinical success: normal blood pressure without the aid of antihypertensive medication Partial clinical success: same blood pressure as before intervention†, with less antihypertensive medication‡ or a reduction in blood pressure with either the same amount or less antihypertensive medication * Absent clinical success: unchanged or increased blood pressure† with either the same amount or an increase in antihypertensive medication
Time frame
6 months3
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up. Hypokalaemia is defined as serum potassium of \<3·6 mmol/L
Time frame
1 month4
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up
Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up. Hypokalaemia is defined as serum potassium of \<3·6 mmol/L
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov