Trial Condition(s):

Heart Failure

REALIsM-HF pilot study (REALIsM-HF)

Bayer Identifier:

19167

ClinicalTrials.gov Identifier:

NCT03507439

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

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

Trial Summary

Enrollment Goal
27
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
VitalPatch
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Northwestern University Feinberg School of Medicine

Chicago, United States, 60611

Status
Completed
 
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

Charité - Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50937

Status
Completed
 

Trial Design