2024-518932-34-00招募中4 期
Effect of metyrapone on cardiovascular risk factors in patients with adrenal incidentalomas and subclinical/mild Cushing's syndrome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- The primary endpoint of the study is the reduction of the number and/or the dose of antihypertensive drugs after 12 months of treatment with Metyrapone, while keeping blood pressure within pre-fixed target range (>100/60 mmHg e <130/85 mmHg)
研究概览
简要总结
The main aim of the study is to investigate the efficacy of adding Metyrapone to the standard antihypertensive treatment in improving blood pressure control of hypertensive patients with SCS and bilateral adrenal tumors
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Run-in Inclusion criteria for run-in phase: - age >18 years and <75 years - monolateral/bilateral nodules with benign radiological characteristics associated with enlarged adrenal limb width >5 mm at CT scan - SCS (absence of catabolic signs of Cushing’s syndrome) associated with at least one of the following conditions: o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and baseline ACTH <10 pg/mL o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and high salivary cortisol at 11 p.m. o Cortisol after 1 mg dexamethasone suppression test >138 nmol/L - Arterial hypertension (blood pressure =140/90 mmHg and/or current treatment with antihypertensive drugs) - Patients who are not candidate for adrenalectomy- Inclusion criteria-randomization (phase 2) - BP >100/60 mmHg and <130/85 mmHg undergoing antihypertensive therapy (lowest effective dose effective dose) within 6-10 months after enrollment-Written informed consent
排除标准
- •Body mass index =40 kg/m2 - Pregnancy or breastfeeding - Women in childbearing age who do not use barrier contraceptives. Barrier contraceptives are: o male or female condom with or without spermicide o cap, diaphragm or sponge with spermicide o a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) - Glucocorticoid treatment during the last year before enrollment - Drugs known to have interactions with Metyrapone - Drug allergy to Metyrapone or drugs belonging to the same class - Patients with severe illness - Patients with primary adrenal insufficiency and severe hypopituitarism - Patients with reduced liver function - Patients with untreated hypothyroidism or taking drugs acting on the hypothalamuspituitary-adrenal axis - Patients with drug hypersensitivity to Metyrapone or to one of the excipients listed in paragraph 6.1 of the summary of product characteristics (SPCs) – Metyrapone.
结局指标
主要结局
The primary endpoint of the study is the reduction of the number and/or the dose of antihypertensive drugs after 12 months of treatment with Metyrapone, while keeping blood pressure within pre-fixed target range (>100/60 mmHg e <130/85 mmHg)
The primary endpoint of the study is the reduction of the number and/or the dose of antihypertensive drugs after 12 months of treatment with Metyrapone, while keeping blood pressure within pre-fixed target range (>100/60 mmHg e <130/85 mmHg)
次要结局
未报告次要终点
研究者
Guido Di Dalmazi
Scientific
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
研究点 (3)
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