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临床试验/EUCTR2015-004498-34-IT
EUCTR2015-004498-34-IT进行中(未招募)1 期

Study on New Insights in Remodeling of Endocrine Cardiomyopathies: ASsessmentt of Intramyocardial, Molecular and NeUroendocrine Parameters in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in AcroMegaly - Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy - Endocrine cardiomyophaty: Response to cyclic GMP PDE5 inhibitors in Acromegaly cardiomyopathy

MBERTO I - POLICLINICO DI ROMA0 个研究点目标入组 15 人开始时间: 2018年1月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • age>18 yrs; patients (men and women) with previous diagnosis of Acromegaly, surgically and/or clinically treated according to current
  • guidelines, with stable parameters of Acromegaly disease in the last 3 months, and with concomitant cardiac hypertrophy and/or diastolic
  • dysfunction developed independently of Acromegaly care and detected by 2D echocardiography
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 1
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 12
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 3

排除标准

  • congenital or valvular cardiomyopathy, recent ischemic heart disease or revascularization after a myocardical infarction (MI), and
  • contraindications to tadalafil 20 mg use (hypersensitivity to tadalafil, nitrates use, severe cardiovascular disorders (in the past 6 months) such as unstable angina or severe heart failure (NYHA II or III), or a stroke or myocardial infarction, heart rhythm problems, blood pressure <90/50 mmHg, severe hepatic or kidney impairment, and known hereditary degenerative retinal disorders such as retinitis pigmentosa, history of NAION)
  • and to MRI examination
  • - pregnant or lactating women

研究者

发起方
MBERTO I - POLICLINICO DI ROMA

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