DAPARHT: DAPAgliflozin for Renal protection in Heart Transplant recipients

Oslo University Hospital0 个研究点目标入组 430 人开始时间: 2021年11月18日最近更新: 2024年2月26日

试验速览

暂无简介。

•Patients will be screened for eligibility during routine follow-up more than 1 year after heart transplant.
•All the following conditions must apply prior to administering the investigational medicinal product:
•Heart transplant recipient for = 1 year.
•Age = 18 years.
•Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.
•Estimated glomerular filtration rate = 25 ml/min/1.73 m2 as assessed by the MDRD formula.
•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 430
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded from the study if they meet any of the following criteria:
•Contraindications to study medication.
•Estimated GFR < 25 ml/min/m2
•Type I diabetes
•Severe liver failure (Child-Pugh’s score C)
•Life expectancy reduced to < 2 years as judged by the investigator
•Unresolved malignant disease
•Failure to obtain written informed consent
•SGL2 inhibitor treatment over the four weeks prior to randomisation
•Breast-feeding

发起方

Oslo University Hospital