EUCTR2020-001544-26-DK进行中（未招募）1 期
Effects of discontinuing renin-angiotensin system inhibitors in patients with and without COVID-19 - RASCOVID-19
Center for Clinical Metabolic Research, Gentofte Hospital0 个研究点目标入组 255 人开始时间: 2020年4月22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
- 255
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
- •For COVID-19-positive participants:
- •1.Verified COVID-19
- •2.Hospital admitted
- •3.Daily administration of RAS-inhibiting therapy
- •4.Age 18 years and above
- •5.Informed consent
- •For COVID-19-negative participants:
- •1.Daily administration of RAS-inhibiting therapy
- •2.Age 18 years and above
- •3.Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 155
排除标准
- •For COVID-19-positive participants:
- •1.Diagnosed with systolic heart failure (heart failure with reduced ejection fraction (EF) (EF<50%))
- •2.Severe kidney disease; defined by estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
- •3.Severe hypertension; defined by systolic pressure > 175 mm Hg and/or diastolic pressure > 105 mm Hg
- •4.Hypotension; defined by systolic pressure < 100 mm Hg and/or diastolic pressure < 60 mm Hg
- •5.Non-compliance of RAS-inhibiting therapy; defined as an estimated adherence <80% assessed by a questionnaire in combination with checking the electronic medication system (Fælles Medicinkort”) for redeemed prescriptions in the last six months; in borderline cases, the participant is assumed compatible
- •6. Presentation with contraindications for continued of ACE inhibitor or ARB treatment including second and third trimester pregnancy, breastfeeding, severe hepatic impairment, hypersensitivity or allergic reactions to the therapy
- •For COVID-19-negative participants:
- •1.Currently admitted to hospital
- •2.Diagnosed with systolic heart failure (heart failure with reduced ejection fraction (EF) (EF<50%))
- •3.Severe kidney disease; defined by estimated glomerular filtration rate (eGFR) ?30 ml/min/1.73 m2
- •4.Severe hypertension; defined by systolic pressure ?175 mm Hg and/or diastolic pressure ?105 mm Hg
- •5.Hypotension; defined by systolic pressure ?100 mm Hg and/or diastolic pressure ?60 mm Hg
- •6.Non-compliance of RAS-inhibiting therapy; defined as an estimated adherence <80% assessed by a questionnaire (Appendix 3) in combination with checking the electronic medication system (Fælles Medicinkort”) for redeemed prescriptions in the last six months; in borderline cases, the participant is assumed compatible
- •7.Presentation with contraindications for continued of ACE inhibitor or ARB treatment including second and third trimester pregnancy, breastfeeding, severe hepatic impairment, hypersensitivity or allergic reactions to the therapy.
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