Stopping ACE-inhibitors in COVID-19 - a randomized, controlled clinical trial

Medizinische Universität Innsbruck0 个研究点目标入组 798 人开始时间: 2020年4月9日最近更新: 2021年6月28日

适应症

试验速览

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•1. Written, signed and dated informed consent form to participate in the clinical trial after prior written and oral information
•2. Male and female patients = 18 years capable of making decisions
•3. Confirmed symptomatic SARS-CoV2 infection (throat swab) = 5 days
•4. Chronic (=1 month) pretreatment with medicinal products from the ATC groups C09A, C09B, C09C, C09D due to arterial hypertension, diabetes mellitus, heart failure or coronary heart disease.
•5. Stable circulatory conditions with not more than four antihypertensive drugs, which allow discontinuation of the therapy with a medicinal product from the ATC groups C09A, C09B, C09C, C09D (systolic arterial blood pressure =180mmHg).
•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 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 638

•1. Women of childbearing potential including pregnant women and breastfeeding mothers
•2. Participation in another interventional study
•3. At the time of study inclusion oral medication is not possible
•4. Acute coronary syndrome =3 months
•5. Heart failure in stages NYHA III and IV
•6. Restriction of left ventricular ejection fraction <30% or NTproBNP increase =600pg/mL in the case of clinical signs of heart failure
•7. Hospitalization due to cardiac decompensation =3 months
•8. Lung failure requiring intubation
•9. Severe arterial hypertension with maximum antihypertensive therapy (taking >4 antihypertensive drugs)
•10. Therapy-refractory arterial hypertension (systolic arterial blood pressure >180mmHg despite multiple therapy)
•11. Patients who cannot be switched to alternative therapy.
•12. Patients who cannot perform a blood pressure self-measurement under ambulant conditions

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