CARNA - Evaluation study to assess medical benefits and positive care effects of app-based, guideline-compliant patient support in heart failure

ProCarement GmbH0 个研究点目标入组 450 人开始时间: 2022年3月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•? Diagnosed heart failure (ICD code I50.-)
•? NYHA- Stadium I, NYHA- Stadium II, NYHA-Stadium III
•? EF < 40% or NT-proBNP > 500
•? Age =18 years
•? Ability to speak and read in German.
•? Ability to use an application running on a smartphone or other mobile device.
•? Informed consent of the study participant.

•? Not owning a smartphone or mobile device with internet access.
•? Cognitive impairment with the inability to give consent to the protocol.
•? Inability or unwillingness to complete app use (e.g. blindness, inadequate German language skills, limited informal self-determination)
•? NYHA IV stage (I50.05 Right heart failure with symptoms at rest NYHA stage IV; I50.14 With symptoms at rest NYHA stage IV)
•? Hospitalisation within the last 8 weeks before inclusion
•? Condition after implantation of a mechanical cardiac assist system
•? Acute coronary syndrome (troponin = 5 x ULN (Upper Limit of Normal)) within the last 8 weeks before inclusion
•? High urgent HTX listing
•? Planned revascularisation, TAVI, mitral clip, etc.
•? Revascularisation and/or CRT implantation within the last 3 months
•? Chronic drug or alcohol abuse as assessed by the physician.
•? Terminal renal failure with haemodialysis treatment (ICD code N18.5)
•? Diseases with a life expectancy of < 12 months
•? Pregnancy
•? Wheelchair use
•? Participation in other intervention studies or other telemedicine programmes
•? Participation in the CARNA pretest study.
•? No valid Corona proof (depending on the regulations of the study centre) at the inclusion examination

发起方

ProCarement GmbH