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临床试验/NCT05797558
NCT05797558招募中不适用

Unilateral Primary Aldosteronism, Mineralocorticoid Antagonists Versus Surgical Treatment - A Randomized Controlled Trial

Göteborg University3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
3
主要终点
Quality of Life (QoL) evaluated with EuroQol-5D at 24 months

研究概览

简要总结

This is a prospective randomized controlled trial where quality of life and the effectiveness of treatment will be evaluated in 80 patients with confirmed unilateral primary aldosteronism ,randomly assigned to be either treated surgically with unilateral adrenalectomy or to receive medical treatment with eplerenone.

详细描述

Background

Primary aldosteronism (PA) is caused by hypersecretion of the adrenal hormone aldosterone and is the most common cause of secondary hypertension . The estimated prevalence of PA is 5-13% in the hypertensive population.

In half of the cases, PA is caused by unilateral hypersecretion of aldosterone, most commonly from an aldosterone producing adenoma. Overproduction from both adrenals is seen in the other half, usually caused by bilateral idiopathic hyperplasia. Unilateral adrenalectomy is considered to be the treatment of choice for unilateral PA and mineralocorticoid receptor antagonists (MRAs, i.e. spironolactone or eplerenone) for bilateral PA . Untreated PA is associated with a greatly increased risk for several comorbidities, especially cardiovascular diseases and renal failure, as well as death.

Studies comparing surgical and medical treatment for PA are scarce. Nevertheless, a recent meta-analysis indicated that cardiovascular outcome is better in surgically than medically treated patients . In addition, quality of life seems to improve more after surgery, and the need for antihypertensive medications, and overall health care consumption,seems to be lower following surgery . However, suboptimal dosing of MRA is common in medically treated patients with PA, which makes a fair comparison between surgically treated patients difficult.

To identify candidates for surgical treatment, adrenal venous sampling (AVS) is necessary to confirm unilateral disease . However, AVS is a technically demanding procedure, with a mean success rate in non-specialized centres of only 32% . This, and the fact that AVS is not widely available, suggests that a substantial number of patients with unilateral PA are never identified and thereby not considered for surgical treatment .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with confirmed unilateral PA
  • Age 18-70 years
  • Candidate for surgical treatment
  • No contraindications for minimally invasive surgery or treatment with MRA
  • Understands oral and written information and provides oral and written informed consent.

排除标准

  • Unwilling or unable to undergo surgery
  • Unwilling to accept medical treatment for 12 months and not receiving standard treatment (surgery)
  • Impaired renal function with eGFR <45 ml/min/1,73m2
  • P-cortisol >138 nmol/L following 1-mg overnight dexamethasone suppression test.

研究组 & 干预措施

Surgically Treated Primary Aldosteronism

Active Comparator

Standard therapy

干预措施: Unilateral adrenalectomy (Procedure)

Medically Treated Unilateral Primary Aldosteronism

Active Comparator

Open label eplerenone treatment

干预措施: Medical treatment (eplerenone) (Drug)

结局指标

主要结局

Quality of Life (QoL) evaluated with EuroQol-5D at 24 months

时间窗: 2 years

Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with EuroQol-5D (EQ-5D-5LTM)

Quality of Life (QoL) evaluated with RAND SF-36 at 12 months

时间窗: 1 year

Improvement in quality of life in surgically and medically treated patients 1 year after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.

Quality of Life (QoL) evaluated with EuroQol-5D at 12 months

时间窗: 1 year

Improvement in quality of life in surgically and medically treated patients 1 year after treatment of unilateral primary aldosteronism evaluated with EuroQol-5D (EQ-5D-5LTM)

Quality of Life (QoL) evaluated with RAND SF-36 at 24 months

时间窗: 2 years

Improvement in quality of life 2 years after treatment of unilateral primary aldosteronism evaluated with RAND SF-36.

次要结局

  • Left ventricular mass(2 year)
  • Albuminuria as a surrogate endpoint of renal function at 24 months(1 year)
  • Clinical outcome based on the Primary Aldosteronism Surgical Outcome (PASO) Criteria(1 year)
  • Biochemical outcome based on the Primary Aldosteronism Surgical Outcome (PASO) Criteria(1 year)
  • Glomerular filtration rate (GFR) as a surrogate endpoint of renal function at 12 months(1 year)
  • Total costs(2 years)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oskar Ragnarsson

MD, PHD, Associate Professor

Göteborg University

研究点 (3)

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