REALIsM-HF Pilot Study (REALIsM-HF)

• ClinicalTrials.gov Identifier: NCT03507439
• Recruitment Status: Completed
• First Posted: April 25, 2018
• Last Update Posted: March 30, 2021
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Device: VitalPatch Biosensor; Device: DynaPort Move Monitor	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Real Life Multimarker Monitoring in Patients With Heart Failure
• Actual Study Start Date: April 6, 2018
• Actual Primary Completion Date: March 12, 2021
• Actual Study Completion Date: March 12, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Heart failure patients; Patients with worsening heart failure (HF) and recent hospitalization for the treatment of HF or patients with chronic stable HF with either preserved (EF ≥ 45%) or reduced ejection fraction (EF ≤ 35%)	Device: VitalPatch Biosensor; Patients will receive the VitalPatch Biosensor system at 5 monitoring periods; Device: DynaPort Move Monitor; Patients will receive the DynaPort Move Monitor (belt) at 2 monitoring periods

Outcome Measures

Primary Outcome Measures :

1. Amount of daily physical activity [ Time Frame: Up to 12 weeks ]
   measured with the VitalPatch Biosensor/ DynaPort Move Monitor device
2. Duration of daily physical activity [ Time Frame: Up to 12 weeks ]
   measured with the VitalPatch Biosensor/ DynaPort Move Monitor device
3. Intensity of daily physical activity [ Time Frame: Up to 12 weeks ]
   measured with the VitalPatch Biosensor/ DynaPort Move Monitor device

Secondary Outcome Measures :

1. 6-minute walking distance (6MWD) [ Time Frame: Up to 12 weeks ]
2. Sleep movements [ Time Frame: Up to 12 weeks ]
   measured with DynaPort Move Monitor device
3. Sleep patterns [ Time Frame: Up to 12 weeks ]
   measured with DynaPort Move Monitor device
4. Sit-to-stand behaviour [ Time Frame: Up to 12 weeks ]
   measured with DynaPort Move Monitor device
5. Quality of Life as measured with the Kansas City Cardiomyopathy Questionnaire score [ Time Frame: Up to 12 weeks ]
   measured using Electronic Patient Research Outcome (ePRO)
6. Biomarkers [ Time Frame: Up to 12 weeks ]
   NTproBNP, hs-Copeptin, hs-TNT
7. Blood pressure [ Time Frame: Up to 12 weeks ]
8. Heart rate [ Time Frame: Up to 12 weeks ]
9. Cardiac function parameters measured by echocardiography [ Time Frame: Up to 12 weeks ]
10. Heart rate variability derived from VitalPatch Biosensor [ Time Frame: Up to 12 weeks ]
11. NYHA class according to the New York Heart Association Functional Classification [ Time Frame: Up to 12 weeks ]
12. Number of participants with adverse events [ Time Frame: Up to 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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: 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 end-diastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure ≥ 20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥ 25 mmHg)
• 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 c) 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

Contacts and Locations

Locations

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Germany

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Nordrhein-Westfalen, Germany, 40225

Universitätsklinikum Köln

Köln, Nordrhein-Westfalen, Germany, 50937

Charité - Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Italy

ASST Spedali Civili di Brescia

Brescia, Lombardia, Italy, 25123

Sponsors and Collaborators

Bayer

More Information

Additional Information:

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03507439
• Other Study ID Numbers: 19167
• First Posted: April 25, 2018
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Bayer:

Heart failure with preserved ejection fraction (HFpEF); Heart failure with reduced ejection fraction (HFrEF)

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases