Table 2.
REALIsM-HF study inclusion and exclusion criteria
| Inclusion criteria |
| Worsening HF requiring hospitalization within the past 72 h for the initiation of intensification of HF therapy with at least 1 of the following: |
| − BNP ≥100 pg/mL or NTproBNP ≥400 pg/mL (sinus rhythm) or BNP ≥300 pg/mL or NTproBNP ≥1,200 pg/mL (atrial fibrillation) |
| − radiographic evidence of pulmonary congestion |
| − catheterization-documented elevated filling pressures at rest or with exercise |
| For HFrEF only: |
| − EF ≤35% during the 3 months before study inclusion |
| For HFpEF only: |
| − EF ≥45% during the 3 months before study inclusion |
| − a willingness and ability to wear the AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor during the trial |
| Exclusion criteria |
| − Inability to comply with planned study requirements |
| − Hemoglobin <10.0 g/dL |
| − Acute coronary syndrome or PCI during the 3 months of informed consent |
| − Listing for heart transplantation and/or anticipated implantation of a ventricular assist device |
| − Inability to exercise or dependence on supplemental oxygen |
| − Known clinically significant persistent coronary ischemia |
| − A major cardiovascular event or surgical procedure during the 3 months before informed consent |
| − PCI, CABG, or implantation of a CRTD planned between randomization and visit 4 |
| − Presence of implantable devices with active minute ventilation sensors |
| − Severe uncorrected valvular heart disease or known clinically relevant ventricular arrhythmias |
| − Severe pulmonary disease |
| − Heavy alcohol consumption or the use of illicit drugs |
| − Regular (more than once per week) participation in swimming or water aerobics |
| − Active myocarditis, primary hypertrophic cardiomyopathy, or constrictive pericarditis or pericardial tamponade |
BNP, brain natriuretic peptide; CABG, coronary artery bypass graft; CRTD, cardiac resynchronization therapy implantable cardioverter defibrillator; EF, ejection fraction; HF, heart failure; HFpEF, HF with preserved EF; HFrEF, HF with reduced EF; MPM, Mobile Patient Management; NTproBNP, N-terminal pro-brain natriuretic peptide; PCI, percutaneous coronary intervention; REALIsM-HF, Real-Life Multimarker Monitoring in Patients with Heart Failure.