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临床试验/NCT07110155
NCT07110155尚未招募不适用

Is the Evolution of the Aldosterone-renin Ratio Pre- Versus Post-operative on Day 1 Following Unilateral Adrenalectomy for Primary Hyperaldosteronism Predictive of Blood Pressure Outcomes

Central Hospital, Nancy, France0 个研究点目标入组 110 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
主要终点
To evaluate the predictive value of the evolution of the ARR between the preoperative period and Day 1 post-surgery on clinical blood pressure outcome

研究概览

简要总结

Primary hyperaldosteronism is characterised by excessive and autonomous aldosterone secretion by the adrenal glands, independent of renin. The condition is characterised by an aldosterone-to-renin ratio (ARR) that exceeds a certain pathological threshold. It manifests as arterial hypertension, which is potentially associated with hypokalaemia due to increased urinary potassium excretion. Excessive and unregulated aldosterone secretion is a validated risk factor for cardiovascular complications.

Primary hyperaldosteronism is estimated to account for 5-20% of hypertension cases and up to 25% of resistant hypertension cases.

Autonomous aldosterone secretion may originate from unilateral secretion by a benign adrenal cortical tumour (Conn's adenoma). Treatment usually involves surgical removal of the hypersecretion source via unilateral adrenalectomy. Alternatively, it can correspond to bilateral adrenal secretion, with or without lateralisation (bilateral adrenal hyperplasia), which is typically managed with antihypertensive medications and/or mineralocorticoid receptor antagonists. In 2021, the HISTOALDO consensus (histology of primary aldosteronism) and the routine use of immunohistochemistry (CYP11B2) made it possible to describe all the histopathological variations between a simple cortical adrenal tumour and bilateral hyperplasia.

Primary hyperaldosteronism due to unilateral or bilateral lesions with lateralised secretion (confirmed by venous sampling or NP53 scintigraphy) usually warrants surgical management via adrenalectomy.

However, while the effectiveness of the treatment is almost guaranteed to cure hypokalaemia, blood pressure changes after surgery remain highly variable, with few criteria available to predict the impact of surgery on blood pressure. Some patients are completely cured and can discontinue all antihypertensive medications, while others experience improvement, allowing a reduction in treatment. A final group shows no change in blood pressure post-adrenalectomy.

The main objective of this study is to evaluate the predictive value of measuring hormone status (aldosterone, renin and ARR) on the first day after surgery for postoperative blood pressure outcomes (clinical criteria: Systolic Blood Pressure).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent unilateral adrenalectomy for primary hyperaldosteronism between 2017 and 2025.

排除标准

  • 未提供

结局指标

主要结局

To evaluate the predictive value of the evolution of the ARR between the preoperative period and Day 1 post-surgery on clinical blood pressure outcome

时间窗: 2-3 months

To evaluate the the evolution of the ARR between the preoperative period and Day 1 post-surgery predicts the clinical blood pressure outcome (clinical PASO criteria) observed two months after unilateral adrenalectomy for lateralized primary hyperald

次要结局

  • To evaluate the predictive value of renin levels on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)(2-3 months)
  • To evaluate the predictive value of aldosterone levels on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)(2-3 months)
  • To determine whether intraoperative blood pressure variations during unilateral adrenalectomy for primary hyperaldosteronism predict postoperative clinical blood pressure outcome (clinical PASO criteria)(2-3 months)
  • To identify patient-related factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)(2-3 months)
  • To evaluate the predictive value of ARR on Day 1 following unilateral adrenalectomy for primary hyperaldosteronism on clinical blood pressure outcome (clinical PASO criteria)(2-3 months)
  • To identify histopathological factors associated with postoperative clinical blood pressure outcome (clinical PASO criteria)(2-3 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

NOMINE-CRIQUI Claire

PH

Central Hospital, Nancy, France

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