REALIsM-HF Pilot Study

Device 1 VitalPatch® biosensor (VitalConnect, USA) Device 2 DynaPort Move Monitor (McRoberts,
NL)

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 within the last 72 hours for the
initiation of intensification of heart failure therapy with at least one of the
following: 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 Radiographic evidence of pulmonary
congestion (interstitial edema, pulmonary venous hypertension, vascular congestion,
pleural effusion) OR Catheterization documented elevated filling pressures at rest
(left ventricular enddiastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure
≥20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥25 mmHg)

- For HFrEF only: EF ≤35% assessed by any imaging modality (e.g. echocardiography,
cardiac magnetic resonance, cine levocardiography) within 3 months prior to study
inclusion

- For HFpEF only: EF ≥45% assessed by any imaging modality (e.g. echocardiography,
cardiac magnetic resonance, cine levocardiography) within 3 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 < 10.0 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

- Subject with implantable devices with active minute ventilation sensors

- 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 or do water aerobics

- 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