Heart Failure

Inclusion Criteria

:
- Written informed consent signed before any study-specific procedure
- Men or women aged 45 years and older
- Established diagnosis of chronic heart failure NYHA class II-IV
- Worsening heart failure requiring hospitalization for the initiation of intensification of heart failure therapy with at least one of the following:  a) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) OR BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation); OR b) Radiographic evidence of pulmonary congestion (interstitial edema, pulmonary venous hypertension, vascular congestion, pleural effusion); OR  c) Catheterization documented elevated filling pressures at rest (left ventricular end-diastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure ≥ 20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥ 25 mmHg)
OR Ambulatory patients with a history of heart failure on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks and at least one of the following: a) Hospitalization for heart failure within the past 12 months; OR b) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) or BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation)
- For HFrEF only: EF ≤35% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion
- For HFpEF only: EF ≥45% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion
- Willingness to wear the DynaPort Move Monitor accelerometer belt and VitalPatch Biosensor during the trial
- Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process

Exclusion Criteria

- Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection, and attending required follow up study visits
- Hemoglobin < 8.0 g/dl
- Acute coronary syndrome or percutaneous coronary intervention within 3 months prior to informed consent
- Listing for heart transplantation and / or anticipated implantation of a ventricular assist device
- Inability to exercise: wheelchair / scooter / walker dependent; dependent on supplemental oxygen
- Known clinically significant persistent coronary ischemia (based on medical history, a preexisting or a recent clinical stress test)
- HF is not the primary factor limiting activity within the last three months as indicated by the patient affirming #1, #2 or #3 of the following questionnaire:  My ability to be active is most limited by: #1 - Joint, foot, leg, hip or back pain; #2 - Unsteadiness or dizziness impairing daily mobility; #3 - Lifestyle, weather, or I just don’t like to be active
- Occurrence of any of the following within 3 months prior to informed consent: Myocardial infarction, Hospitalization for unstable angina, Stroke or transient ischemic attack, Coronary artery bypass graft (CABG), Percutaneous coronary intervention (PCI), Implantation of a cardiac resynchronization therapy device (CRTD), Major surgery (that could interfere with patients’ ability to exercise)
- PCI, CABG or implantation of a CRTD planned between randomization and Visit 4
- Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG lead II orientation)
- Subject with known allergies or hypersensitivities to adhesives or hydrogels
- Severe uncorrected valvular heart disease
- Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation)
- Severe pulmonary disease with any of the following: Requirement of continuous (home) oxygen or History of chronic obstructive pulmonary disease ≥ GOLD III
- Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s)
- Any condition or therapy, which would make the patient unsuitable for the study, or life expectancy less than 12 months (e.g. active malignancy)
- Heavy alcohol consumption or the use of illicit drugs that, in the opinion of the investigator, may interfere with the patient’s safety and / or compliance
- Patients who regularly (> 1x per week) swim, do water aerobics or go to the sauna, unwilling to omit this activity while needing to wear the study specific medical devices
- Active myocarditis
- Primary hypertrophic cardiomyopathy
- Constrictive pericarditis or pericardial tamponade
- Close affiliation with the investigational site, e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
- Previous participate in the study