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

Primary Purpose

Primary Aldosteronism

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ablation of aldosterone secreting adenoma
Unilateral adrenalectomy
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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):

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

Sites / Locations

  • St Bartholomew's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Radiofrequency ablation of adrenal aldosterone producing adenoma (s)

Unilateral adrenalectomy for aldosterone producing adenoma(s)

Arm Description

Ablation of adrenal aldosterone producing adenoma(s)

Unilateral adrenalectomy for laldosterone producing adenoma(s)

Outcomes

Primary Outcome Measures

Normalisation of ARR
Normalisation of aldosterone renin ratio
Change in systolic and diastolic blood pressure
Home blood pressure average for systolic and diastolic measurements in mmHg

Secondary Outcome Measures

Adverse events
recording of adverse events at study timepoints
Safety bloods
Safety bloods including Full blood count Electrolytes and urea Amylase/lipase Liver function test serum metanephrines
Patient satisfaction questionnaire
Patient satisfaction following intervention using the Freiuburg questionnaire, patient will score 1 to 6 their satisfaction with treatment, with 1 being excellent and 6 being very poor.
Quality of Life Questionnaire
Quality of life questionnaire SF36 short form, patient will complete and a multi - item questionnaire and score how they are feeling, the higher the score, the higher the well being.
Return to work
Return to work self reported
Anatomical efficacy using CETO PET CT (for radiofrequency ablation arm only
CETO PET CT following radiofrequency ablation for efficacy and change in appearance of aldosterone producing adenoma

Full Information

First Posted
March 15, 2022
Last Updated
July 25, 2023
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT05405101
Brief Title
A Prospective Randomised Trial Comparing Radiofrequency Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism
Acronym
WAVE
Official Title
A Prospective Randomised Trial Comparing Radiofrequency Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
PROBE: Prospective Randomised open blinded end point study.
Masking
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.
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation of adrenal aldosterone producing adenoma (s)
Arm Type
Experimental
Arm Description
Ablation of adrenal aldosterone producing adenoma(s)
Arm Title
Unilateral adrenalectomy for aldosterone producing adenoma(s)
Arm Type
Other
Arm Description
Unilateral adrenalectomy for laldosterone producing adenoma(s)
Intervention Type
Procedure
Intervention Name(s)
ablation of aldosterone secreting adenoma
Intervention Description
Radio frequency ablation to Conn's adenoma(s)
Intervention Type
Procedure
Intervention Name(s)
Unilateral adrenalectomy
Intervention Description
Unilateral adrenalectomy for aldosterone secreting adenoma
Primary Outcome Measure Information:
Title
Normalisation of ARR
Description
Normalisation of aldosterone renin ratio
Time Frame
12 months
Title
Change in systolic and diastolic blood pressure
Description
Home blood pressure average for systolic and diastolic measurements in mmHg
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
recording of adverse events at study timepoints
Time Frame
12 months
Title
Safety bloods
Description
Safety bloods including Full blood count Electrolytes and urea Amylase/lipase Liver function test serum metanephrines
Time Frame
12 months
Title
Patient satisfaction questionnaire
Description
Patient satisfaction following intervention using the Freiuburg questionnaire, patient will score 1 to 6 their satisfaction with treatment, with 1 being excellent and 6 being very poor.
Time Frame
12 months
Title
Quality of Life Questionnaire
Description
Quality of life questionnaire SF36 short form, patient will complete and a multi - item questionnaire and score how they are feeling, the higher the score, the higher the well being.
Time Frame
12 months
Title
Return to work
Description
Return to work self reported
Time Frame
12 months
Title
Anatomical efficacy using CETO PET CT (for radiofrequency ablation arm only
Description
CETO PET CT following radiofrequency ablation for efficacy and change in appearance of aldosterone producing adenoma
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): Spontaneous or thiazide-induced hypokalaemia, PAC >550pmol/L and PRA <0.5nmol/L/h or DRC <2.5pg/mL 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aklima Khatun
Phone
0203 765 8577
Email
aklima.khatun4@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Tumi Kaminsas
Phone
0207 882 5994
Email
research.governance@qmul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morris Brown
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Drake, FRCP DM
Email
w.m.drake@qmul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once discussed with patient representative from patient and public Involvement, document will be uploaded on to system following first Steering committee involving PPI member

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

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