WAVE: A Prospective Randomised Trial Comparing Radiofrequency Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05405101
• Collaborator: (none)
• Enrollment: 110
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

A prospective randomised trial comparing radiofrequency ablation With laparoscopic Adrenalectomy as an alternatiVE treatment for unilateral asymmetric primary aldosteronism

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Procedure: ablation of aldosterone secreting adenoma; Procedure: Unilateral adrenalectomy	N/A

Detailed Description

The primary objective of WAVE is to test the hypothesis that RFA is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria.

Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of RFA against LA will be sought.

• Frequency and severity of adverse events

• Length of inpatient stay

• Patient satisfaction

• Quality of life

• Return to work

An additional secondary objective in the RFA group alone will be anatomical efficacy of ablation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: PROBE: Prospective Randomised open blinded end point study.PROBE: Prospective Randomised open blinded end point study.
• Masking: Single (Outcomes Assessor)
• Masking Description: WAVE is a Prospective randomized trial comparing radiofrequency ablation with laparoscopic adrenalectomy in patients with primary aldosteronism. The study will use minimisation method for randomisation.
• Primary Purpose: Treatment
• Official Title: A Prospective Randomised Trial Comparing Radiofrequency Ablation With Laparoscopic
• Anticipated Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Jan 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiofrequency ablation of adrenal aldosterone producing adenoma (s) Ablation of adrenal aldosterone producing adenoma(s)	Procedure: ablation of aldosterone secreting adenoma; Radio frequency ablation to Conn's adenoma(s)
Other: Unilateral adrenalectomy for aldosterone producing adenoma(s) Unilateral adrenalectomy for laldosterone producing adenoma(s)	Procedure: Unilateral adrenalectomy; Unilateral adrenalectomy for aldosterone secreting adenoma

Outcome Measures

Primary Outcome Measures

1. Normalisation of ARR [12 months]

   Normalisation of aldosterone renin ratio

2. Reduction in systolic and diastolic blood pressure [12 months]

   Home blood pressure average for systolic and diastolic measurements in mmHg

Secondary Outcome Measures

1. Adverse events [12 months]

   recording of adverse events at study timepoints

2. Safety bloods [12 months]

   Safety bloods including Full blood count Electrolytes and urea Amylase/lipase Liver function test serum metanephrines

3. Patient satisfaction [12 months]

   Patient satisfaction following intervention using the Freiuburg questionnaire

4. Quality of Life [12 months]

   Quality of life questionnaire SF36 short form

5. Return to work [12 months]

   Return to work self reported

6. Anatomical efficacy using CETO PET CT (for radiofrequency ablation arm only [12 months]

   CETO PET CT following radiofrequency ablation for efficacy and change in appearance of aldosterone producing adenoma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

• Primary aldosteronism according to international guidelines11,14

1. An elevated ARR (according to local reference ranges), and at least one of (when measured off confounding medications):

2. Spontaneous or thiazide-induced hypokalaemia, PAC >550pmol/L and PRA <0.5nmol/L/h or DRC <2.5pg/mL

3. A positive saline infusion test (SIT)

• Four-hour aldosterone >190pmol/L 3. A positive captopril suppression test (CST), either:

• Failure to suppress two-hour aldosterone by >30% and persistent suppression of PRA/DRC11, or

• Two-hour aldosterone > 300 pmol/L14

• Unilateral PA, defined by at least one of the following criteria:

1. ACTH-stimulated AVS24

• Selectivity index (SI) >3, and

• Lateralisation index (LI) > 4 2. Non-ACTH-stimulated AVS24

• SI > 2, and

• LI > 3, and

• Contralateral suppression index (CSI) < 0.5/1 3. Metomidate/CETO PET-CT25

• 25% higher PET signal (maximum standardised uptake value) over an adenoma compared to the contralateral adrenal 4. Age <35, unilateral adrenal lesion with normal contralateral gland11

• Radiological abnormality ipsilateral to side of lateralisation, which is:

1. Benign:

• Unenhanced CT attenuation <20HU, or

• Post-contrast CT absolute washout >60%, or

• Post-contract CT relative washout >40%, or

• Signal drop-out on out-of-phase MRI 2. Technically amenable to both RFA and surgery (determined at MDT review)

• Able and willing to give informed consent

Exclusion Criteria:

• Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast, or

• Contraindication or unwillingness for either surgery or RFA, or

• Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks, or

• Unwilling to undergo either LA or RFA, or

• Unwilling to comply with study visit schedule, or

• Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only), or

• Life-limiting comorbidity (at the discretion of the PI)

• Clinical and/or biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Queen Mary University of London

Investigators

• Principal Investigator: Morris Brown, Pof, Queen Mary University of London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT05405101
• Other Study ID Numbers: 304174
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Queen Mary University of London: ablation
• Additional relevant MeSH terms: Hyperaldosteronism

Study Results

No Results Posted as of Jun 6, 2022