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| Go ahead for PASSPORT-HF by ethics committee

The ethics committee has evaluated the clinical investigation plan and has provided favourable opinion for the PASSPORT-HF study without further requirements.

 

PASSPORT-HF is one of the first studies to examine the opportunities and advantages of telemedical heart failure care in the statutory national health system. It is designed for patients who had been predominantly diagnosed with stage NYHA III one month prior to recruitment and who had been hospitalized at least once within the year prior to the study. Under the scientifc guidance of Professor Stefan Störk (Comprehensive Heart Failure Center-DZHI), the study investigates two types of therapy. Both groups are to receive their primary medical treatment based on regular telephone interviews and self-monitoring and recording of blood pressure, pulse, weight and symptoms of heart failure. Additional, a sensor is implanted to patients of the intervention group, which continuously monitors the pressure in the pulmonary artery. These values can be regularly observed and therapy and medication may be adjusted immediately via remote access. The sensor has already been successfully tested in the USA as part of the CHAMPION study. Due to the differing organizational structures of the health care systems, particularly in the field of follow-up monitoring, the PASSPORT-HF study will have to show whether telemedical monitoring is also beneficial to the statutory national health system.

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