Status:
COMPLETED
Radiofrequency Endoscopic Ablation With Ultrasound Guidance: a Non-surgical Treatment for Aldosterone-producing Adenomas
Lead Sponsor:
University College, London
Collaborating Sponsors:
Queen Mary University of London
British Heart Foundation
Conditions:
Primary Hyperaldosteronism
Primary Hyperaldosteronism Due to Adrenal Adenoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
High blood pressure (hypertension) causes strokes and heart attacks. While most patients need long-term treatment with pills, some have a cause which can be removed, curing the hypertension. The commo...
Detailed Description
Primary hyperaldosteronism (PA) is one of the commonest causes of hypertension. It is estimated to be the root cause in 10% of all patients with hypertension and 20% of all patients with resistant hyp...
Eligibility Criteria
Inclusion
- Patients aged 18 and above
- Diagnosis of PHA based on published Endocrine Society guidelines
- Positive serum aldosterone renin ratio (ARR) with another local diagnostic confirmatory test (MRI or CT imaging)
- There are 3 inclusion subset groups:
- Group 1
- Left-sided APA proven on either AVS or PET CT.
- Patients wishing to take fewer drugs for their hypertension.
- Patients not usually referred for surgery because the benefit: risk is considered too low.
- Patients aged ≥60 whose BP is at or near target (BP140/90 for most patient groups, BP 130/80 if co-morbidities listed in Hypertension guidelines) on treatment with four or more drugs.
- patients with identified macroadenomas (APAs \>= 1 cm in diameter), who have at least 1 cm of peri-adrenal fat on axial and coronal projections.
- Group 2
- Patients aged 18 years and above with diagnosis of PA and either:
- \[i\] a definite unilateral left APA, but the patient does not want surgery; or \[ii\] probable but not unequivocal evidence of a unilateral left adrenal APA.
- Group 3 Patients over 18 years of age meeting criteria for surgery, but consent to undergo endoscopic ablation instead.
Exclusion
- Inability to give informed consent.
- Any patients continuing on beta blockers/direct renin blockers.
- Pregnant women or those unable or unwilling to take secure contraceptive precautions.
- Any illness, condition or drug regimen considered a contraindication by the PI/CI.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03405025
Start Date
February 21 2018
End Date
May 10 2023
Last Update
May 12 2023
Active Locations (3)
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1
University of Cambridge and Cambridge NIHR Biomedical Research Centre
Cambridge, United Kingdom
2
Queen Mary University of London
London, United Kingdom, EC1M 6BQ
3
University College London
London, United Kingdom, NW3 2QG