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临床试验/NCT07621458
NCT07621458招募中不适用

Impact of the Revised Aldosterone-Renin Ratio (ARR) Cutoff in the 2025 Primary Aldosteronism Guideline in Real-World Practice: A Prospective Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1

研究概览

简要总结

The goal of this observational study is to evaluate the real-world impact of applying the revised aldosterone-to-renin ratio (ARR) cutoff recommended in the 2025 primary aldosteronism guideline in adults with hypertension and biochemical findings suggestive of an intermediate probability of lateralizing primary aldosteronism (PA). The main questions it aims to answer are:

  • What is the number needed to test (NNT) to diagnose one case of primary aldosteronism when using the revised ARR cutoff (>20)?
  • What is the optimal ARR cutoff for diagnosing PA in Korean patients?
  • What is the biochemical treatment response rate at 6 months after treatment for confirmed PA?

Participants will:

  • Undergo standardized ARR testing after protocol-based medication adjustment and controlled sampling conditions.
  • Undergo confirmatory testing using the saline infusion test (SIT).
  • Receive standard clinical management for confirmed PA according to institutional practice.
  • Be followed for assessment of biochemical outcomes after treatment.

详细描述

Primary aldosteronism (PA) is one of the most common causes of secondary hypertension and is associated with an increased risk of cardiovascular, renal, and metabolic complications independent of blood pressure levels. Despite its clinical importance and the availability of effective targeted treatments such as adrenalectomy or mineralocorticoid receptor antagonists, PA remains substantially underdiagnosed in routine clinical practice, with estimates suggesting that only a small proportion of eligible hypertensive patients undergo appropriate screening.

The aldosterone-to-renin ratio (ARR) is the most widely used screening tool for PA. Traditionally, an ARR cutoff of >30 has been used to define a positive screening result. However, recent evidence suggests that this threshold may lack sufficient sensitivity and may miss a considerable number of patients with clinically relevant PA. In response, recent international hypertension and endocrine society guidelines have proposed lowering the ARR cutoff to >20 in order to improve case detection and broaden screening indications.

However, lowering the ARR threshold may also increase the number of false-positive results, potentially leading to an increased burden of aldosterone suppression test. Therefore, the clinical utility of the revised cutoff must be evaluated in real-world settings, particularly with regard to diagnostic yield and testing efficiency.

This study is a multicenter, prospective observational cohort study designed to evaluate the impact of applying the revised ARR cutoff (>20) in routine clinical practice in Korea. Patients with hypertension who meet predefined biochemical screening criteria indicating an intermediate probability of lateralizing PA will be enrolled.

Participants will undergo standardized pre-analytical preparation, including medication adjustment and controlled sampling conditions. All eligible participants will undergo confirmatory testing using the saline infusion test (SIT), performed under standardized protocols (supine or seated depending on institutional practice).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Diagnosis of hypertension or current use of antihypertensive medications
  • Plasma renin activity (PRA) ≤1 ng/mL/hr
  • Plasma aldosterone concentration (PAC) ≥10 ng/dL by immunoassay or ≥7.5 ng/dL by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
  • Aldosterone-to-renin ratio (ARR) >20 by immunoassay or >15 by LC-MS/MS
  • Participants meeting criteria for intermediate probability of lateralizing primary aldosteronism
  • For participants with ARR values between 20 and 30, repeat ARR measurement within 26 weeks demonstrating persistent ARR >20

排除标准

  • Current use of mineralocorticoid receptor antagonists or amiloride that cannot be discontinued according to study protocol
  • Previous adrenalectomy
  • Chronic kidney disease stage 4 or higher (estimated glomerular filtration rate <30 mL/min/1.73 m²)
  • Pregnancy
  • Current use of combined estrogen- and progesterone-containing oral contraceptive pills or hormone replacement therapy
  • High probability primary aldosteronism defined as hypokalemia with PRA <0.2 ng/mL/hr and PAC >20 ng/dL by immunoassay or >15 ng/dL by LC-MS/MS
  • Low probability primary aldosteronism defined as PAC <11 ng/dL by immunoassay or <8 ng/dL by LC-MS/MS
  • Inability to undergo saline infusion test according to investigator judgment

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung Hee Kim

Principal Investigator

Seoul National University Hospital

研究点 (1)

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