Telemonitoring and telemedicine in patients with cardiovascular diseases
Cardiovascular diseases (CVDs) are the number 1 cause of death globally and represent a major economic burden on health care systems. Remote monitoring and telemonitoring with active intervention are beneficial in several cardiovascular diseases. For these patients, a novel integrated care concept (NICC) has been developed which combines telemedicine, e.g., daily blood pressure monitoring, with telemonitoring in a call center and guideline therapy for patients. The aim of the study is to show that NICC is preferable over guideline therapy alone.
The trial CardioCare MV is part of the project HerzEffekt MV, which is funded by the innovation fond of the German Joint Federal Committee (funding code: 01NVF1603). Primary grantee of CardioCare MV is the University Medical Center of Rostock. Team members of Cardio-CARE in Davos were involved in the planning and the conduct of the CardioCare MV trial and are currently performing the analyses of the trial.
The target was to include 964 patients in the trial. The inclusion of patients into the trial started in December, 2017, and the 1-year follow-up of the last patient was completed in 2020. Randomization was be done individually with stratification by the cardiovascular diseases atrial fibrillation, heart failure or treatment-resistant hypertension and inpatient or outpatient status. Endpoints are based on the 1-year observation period after randomization. The first primary endpoint is the composite endpoint consisting of mortality, stroke and myocardial infarction.
The number of hospitalizations form the second primary endpoint. The third primary endpoint is identical to the first primary endpoint plus cardiac decompensation. Secondary endpoints include health care costs, quality of life and safety.
