ISRCTN91387205已完成未知
Is metomidate PET-CT superior to adrenal venous sampling in predicting outcome from adrenalectomy in patients with primary hyperaldosteronism? (MATCH): a multi-centre, randomised, within-patient comparison of diagnostic techniques
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 143
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36646800/ (added 13/02/2024)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Male or female age >18 years
- •2. Diagnosis of PHA based on published Endocrine Society consensus guidelines
- •3. Patients will be enrolled/consented when they have had each of the following:
- •3.1. At least one paired measurement of plasma renin and aldosterone, measured off spironolactone, showing an elevated ARR
- •3.2. Either a plasma aldosterone >190 pmol/L after saline infusion or ‘spontaneous hypokalemia + plasma renin below detection levels + plasma aldosterone > 550 pmol/L)’ (as per Endocrine Society guidance)
- •3.3. A CT or MRI scan of the adrenals with probable or definite adenoma(s)
- •4. Patients with elevated ARR can be put forward for consideration by the MDT as exceptional cases in whom spironolactone is not (fully) withdrawn, and/or saline suppression is not performed, IF:
- •4.1. Plasma Aldosterone > 450 pmol/L AND plasma renin <0.5 pmol/ml/hr (<9 mU/L) if measured on treatment with ACEI (Lisinopril >=20 mg or equivalent) or ARB (Losartan 100 mg or equivalent); OR
- •4.2. Age <40 AND definite adrenal adenoma on CT or MRI Patients whose CT/MRI does not show probable or definite adenoma must also be reviewed by MDT before enrolment/consent
- •5. All patients will have a positive Aldosterone renin ratio (ARR) serum measurement with another local diagnostic confirmatory test as specified from local specialised APA Guidelines. This is often standard cross-sectional imaging by CT or MR scanning. Any exception to recommended diagnostic criteria will be subject to approval by monthly MDT
排除标准
- •1. Those patients who indicate that they are unlikely to proceed with surgery will not be recruited, because there will be no outcome change in blood pressure, restoration of normal renin/angiotensin physiology) against which to compare the accuracy of the two Investigations
- •2. Patients contraindicated for spironolactone therapy
- •3. Any patients continuing on beta-blockers or direct renin blockers
- •4. Pregnant/breastfeeding females or women unable/unwilling to take secure contraceptive precautions whilst undergoing investigations
- •5. Patients unwilling/unable to take the dexamethasone required to prepare for a metomidate PET-CT scan
- •6. Any illness, condition or drug regimen that is considered a contraindication by the PI
研究者
相似试验
已完成
不适用
IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary HyperaldosteronismHyperaldosteronismPrimary AldosteronismNCT02945904Queen Mary University of London190
招募中
不适用
Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary AldosteronismPrimary AldosteronismNCT06238232Qifu Li320
Unknown
2 期
11C Methionine PET for the Detection of Hyperfunctional Parathyroid TissuesPrimary HyperparathyroidismNCT01783002University of British Columbia50
招募中
不适用
Adrenal gland scanning using PET/CT with a specific tracer (11C-metomidate) in patients with hypertension due to overproduction of aldosterone.hypertensionprimary aldosteronismadrenal venous samplingNL-OMON28757niversity Medical Center GroningenHanzeplein 19700 RB GroningenThe Netherlands10
招募中
不适用
CXCR4-directed [68Ga]Ga-PentixaFor vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS trial)Primary aldosteronismNL-OMON28682Radboudumc265