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临床试验/NCT04761354
NCT04761354已完成不适用

Characteristics Predicting Clinically Relevant Reduction of Hypertension Following Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis

UMC Utrecht14 个研究点 分布在 5 个国家目标入组 514 人开始时间: 2016年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
514
试验地点
14
主要终点
Postoperative blood pressure measurement

研究概览

简要总结

Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both.

After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure <140 and diastolic blood pressure <90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups.

Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results.

The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling.

研究设计

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

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

  • All patients who underwent unilateral adrenalectomy between 2010 and 2016 for APA.
  • Patients with biochemical evidence of primary aldosteronism who underwent adrenalectomy on account of an aldosterone-producing adenoma(APA), proven by Computerized Tomography(CT) or Magnetic Resonance Imaging(MRI) or Adrenal Venous Sampling(AVS).

排除标准

  • Age <18 years.
  • Missing or incomplete data about preoperative blood pressure and number of antihypertensive drugs.
  • Missing or incomplete follow-up data about postoperative blood pressure and number of antihypertensive drugs. We aim enter the blood pressure and number of antihypertensive drugs closest to 6 months after adrenalectomy.

结局指标

主要结局

Postoperative blood pressure measurement

时间窗: 6 months postoperative

systolic and diastolic blood pressure via office blood pressure measurements

resolution of hypertension

时间窗: 6 months postoperative

resolution of hypertension score via the PASO consensus criteria

antihypertensive medication use

时间窗: 6 months postoperative (corresponding to the entered postoperative blood pressure)

number of antihypertensives in defined daily dose

次要结局

  • Pathology(6 months postoperative)
  • Postoperative plasma creatinine level(6 months postoperative)
  • Postoperative serum potassium level(6 months postoperative)
  • Postoperative aldosterone to renin ratio(6 months postoperative)
  • Postoperative plasma aldosterone level in lying and standing position(6 months postoperative)
  • Postoperative plasma renin activity in lying and standing position(6 months postoperative)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. M.R. Vriens

Professor in Endocrine and Oncological Surgery

UMC Utrecht

研究点 (14)

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