Study design and participants
stroke, cardiac decompensation
RECRUITMENT, MYOCARDIAL INFARCTION, STROKE, WEST, HEART, CARDIAC DECOMPENSATION
CardioCare MV was a prospective, randomized, controlled, parallel-group, open-label, blinded-observer trial that aimed to demonstrate NICC’s superiority over SoC according to three hypotheses: (1) NICC is superior to SoC in terms of the combined endpoint comprising mortality, stroke, or myocardial infarction, which should be decreased under NICC versus SoC at 12 month follow-up; (2) NICC results in a lower number of inpatient treatment days versus SoC at 12 month follow-up; (3) NICC results in a lower proportion of patients achieving the combined endpoint of mortality, stroke, myocardial infarction, or cardiac decompensation versus SoC at 12 month follow-up. Details on trial design and statistical analysis plan were formerly reported [Initially, recruited patients were referred by a cardiologist/physician to the recruiting University Medical Centre Rostock (UMR) centre, as were UMR inpatients. Patients aged ≥ 18 years with HF New-York Heart Association (NYHA) II-IV, AF European Heart Rhythm Association (EHRA) II-IV, or TRH with blood pressure ≥ 140/90 mmHg or ≥ 4 anti-hypertensives including at least one diuretic were invited to provide their informed written consent. They were residents of Mecklenburg West Pomerania and members of the health insurance companies The study was conducted according to the most recent Helsinki Declaration version. The protocol was approved by the Ethics Committee of Rostock University Medical Faculty on 18th July 2017 (file number: A 2017–0117); it was registered with drks.de (registration number: DRKS00013124) on 5th October 2017, and secondarily with ClinicalTrials.gov (registration number: NCT03317951) on 17th October 2017. Recruitment started on 1st December 2017.The project was supervised by both a steering Committee and independent data monitoring committee, which oversaw the safety of care concepts, along with data collection and study conduct.