Heart FailureREALIsM-HFNCT03507439
REALIsM-HF Pilot Study
A study testing AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor and DynaPort Move Monitor in people with Heart Failure, run by Bayer at 5 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor and DynaPort Move Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 6 Apr 2018to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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 locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Charité - Campus Virchow-Klinikum (CVK)
Berlin, 13353
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Real Life Multimarker Monitoring in Patients With Heart Failure
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.
Read the detailed description
Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)
- Conditions
- Heart Failure
- Being tested
- AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor, DynaPort Move Monitor
- Keywords
- Heart failure with preserved ejection fraction (HFpEF), Heart failure with reduced ejection fraction (HFrEF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIVO Mobile Patient Management (MPM) SystemDevice
Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
VitalPatch biosensorDevice
Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
DynaPort Move MonitorDevice
Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | Experimental | Participants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. Receives: Device: AVIVO Mobile Patient Management (MPM) System; Device: VitalPatch biosensor; Device: DynaPort Move Monitor |
| HFpEF | Experimental | Participants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. Receives: Device: AVIVO Mobile Patient Management (MPM) System; Device: VitalPatch biosensor; Device: DynaPort Move Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Steps Count
Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Measured: At Day 9 and Day 77
Daily Physical Activity Level
Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity.
Measured: At Day 9 and Day 77
Total Daily Energy Expenditure
Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Measured: At Day 9 and Day 77
Duration of Daily Physical Activity
Duration of daily physical activity was measured with DynaPort Move Monitor device.
Measured: At Day 9 and Day 77
Time Duration Per Activity Status
Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more.
Measured: At Day 9 and Day 77
Amount of Daily Physical Activity Measured With VitalPatch Biosensor
Amount of daily physical activity was collected and measured with VitalPatch biosensor.
Measured: Up to Day 84
Duration of Daily Physical Activity Measured With VitalPatch Biosensor
Duration of daily physical activity was collected and measured with VitalPatch biosensor.
Measured: Up to Day 84
Intensity of Daily Physical Activity Measured With VitalPatch Biosensor
Intensity of daily physical activity was collected and measured with VitalPatch biosensor.
Measured: Up to Day 84
Secondary outcomes (33)
6-minute Walking Distance (6MWD)
6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.
Measured: At Day 84
Sleep Movements
Sleep movements was measured with DynaPort Move Monitor device.
Measured: Up to Day 84
Sleep Patterns
Sleep patterns was measured with DynaPort Move Monitor device.
Measured: Up to Day 84
Sit-to-stand Behaviour
Sit-to-stand behaviour was measured with DynaPort Move Monitor device.
Measured: Up to Day 84
Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the leading health-related quality-of-life measure for patients with heart failure (HF). It is a 23-item questionnaire that independently measures the impact of patients' HF, or its treatment, on 7 distinct domains: symptom frequency, symptom burden, physical limitation, quality of life, social limitations, self-efficacy and symptoms stability. Physical Limitation ranges 0-100. Total Symptom Score (range 0-100) combines the Symptom Frequency and the Symptom Burden scores; Clinical Summary Score (range 0-100) combines the Total Symptom and Physical Limitation scores to replicate the NYHA classification; Overall Summary Score (range 0-100) includes the Total Symptom, Physical Limitation, Social Limitations, and Quality of Life scores. Higher scores indicate more favorable states.
Measured: At Day 9 and Day 84
Quality of Life as Measured With the PRO - Activity Scores
REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Overall activity score ranges from 0 to 240 and general physical activity score ranges from 0 to 4. Higher scores indicate more favorable states.
Measured: At Day 9 and Day 77
Quality of Life as Measured With the PRO - Change in Activities and Symptoms
REALIsM-HF exploratory daily questionnaire was developed to include patient-reported outcome (PRO) items that can be administered as a daily diary in the study. Answers to question "How have your physical activities changed since you were discharged from the hospital": 1= Very much more physically active; 2= Much more physically active; 3= A little more physically active; 4= No change in physical activities; 5= A little less physically active; 6= Much less physically active; 7= Very much less physically active. Answers to questions "How has your feeling of tiredness changed since you were discharged from the hospital", "How has your shortness of breath changed since you were discharged from the hospital" and "How has your swelling in your legs, ankles, or feet changed since you were discharged from the hospital": 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse.
Measured: At Day 9 and Day 77
Copeptin
Blood sample for biomarkers including Copeptin were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Measured: At Day 9 and Day 84
Galectin-3
Blood sample for biomarkers including Galectin-3 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Measured: At Day 9 and Day 84
Growth Differentiation Factor 15 (GDF 15)
Blood sample for biomarkers including GDF 15 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Measured: At Day 9 and Day 84
Human Interleukin-1 Receptor 4 / ST2 (sST2)
Blood sample for biomarkers including sST2 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values above upper limit of quantification (ULOQ) were substituted by ULOQ for the calculation of statistics (ULOQ = 80.0)
Measured: At Day 9 and Day 84
Human Insulin-like Growth Factor Binding (IGFBP7)
Blood sample for biomarkers including IGFBP7 were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Measured: At Day 9 and Day 84
N-terminal Propeptide of BNP (NT-proBNP)
Blood sample for biomarkers including NT-proBNP were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls.
Measured: At Day 9 and Day 84
High Sensitive Troponin T (hsTRT)
Blood sample for biomarkers including hsTRT were collected from participants in order to validate such biomarkers for clinical use in the context of heart failure. Biomarkers concentration was determined in plasma/serum by a central laboratory using validated assays platforms including appropriate quality controls. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation of statistics (LLOQ = 13.0)
Measured: At Day 9 and Day 84
Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were collected.
Measured: At Day 9, Day 77 and Day 84
Heart Rate
Heart rate data were collected by electrocardiogram (ECG).
Measured: At Day 9, Day 77 and Day 84
Interventricular Septal Wall Thickness
Interventricular septal wall thickness was measured by echocardiography.
Measured: At Day 84
Diameter of the Left Ventricle in Diastole
Diameter of the left ventricle in diastole was measured by echocardiography.
Measured: At Day 84
Diameter of the Left Ventricle in Systole
Diameter of the left ventricle in systole was measured by echocardiography.
Measured: At Day 84
Left Ventricular End-diastolic Volume
Left ventricular end-diastolic volume was measured by echocardiography.
Measured: At Day 84
Left Ventricular End-systolic Volume
Left ventricular end-systolic volume was measured by echocardiography.
Measured: At Day 84
Left Ventricular Ejection Fraction
Left ventricular ejection fraction was measured by echocardiography.
Measured: At Day 84
Left Atrial End-systolic Volume
Left atrial end-systolic volume was measured by echocardiography.
Measured: At Day 84
Left Atrial End Systolic Volume Index
Left atrial end systolic volume index was measured by echocardiography.
Measured: At Day 84
Mitral Peak Velocity of Early Filling (E)
Mitral peak velocity of early filling (E) was measured by echocardiography.
Measured: At Day 84
Mitral Peak Velocity of Late Filling (A)
Mitral peak velocity of late filling (A) was measured by echocardiography.
Measured: At Day 84
Mitral Lateral Annulus Early Diastolic Peak Velocity
Mitral lateral annulus early diastolic peak velocity was measured by echocardiography.
Measured: At Day 84
Mitral Septal Annulus Early Diastolic Peak Velocity
Mitral septal annulus early diastolic peak velocity was measured by echocardiography.
Measured: At Day 84
Tricuspid Annular Plane Systolic Excursion
Tricuspid annular plane systolic excursion was measured by echocardiography.
Measured: At Day 84
Pressure Gradient of Tricuspid Valve
Pressure gradient of tricuspid valve was measured by echocardiography.
Measured: At Day 84
Right Atrial Mean Pressure
Right atrial mean pressure was measured by echocardiography.
Measured: At Day 84
Heart Rate Variability (HRV) Derived From ECG
Heart rate variability (HRV) derived from ECG were measured with AVIVO MPM and VitalPatch biosensor
Measured: Up to Day 84
Number of Participants Per NYHA Classification by Visit
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. The Stages of Heart Failure: Class I = No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II = Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III = Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20 - 100 m). Comfortable only at rest. Class IV = Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Measured: At Day 9 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start6 Apr 2018
- Primary completion30 Dec 2020
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507439
- Sponsor's protocol ID
- 19167
- Acronym
- REALIsM-HF
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2018
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Multimarker Monitoring in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03507439
- Acronym / sponsor ID
- REALIsM-HF / 19167
- Conditions
- Heart Failure
- Keywords
- Heart failure with preserved ejection fraction (HFpEF), Heart failure with reduced ejection fraction (HFrEF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFrEF | Experimental | Device: AVIVO Mobile Patient Management (MPM) System, Device: VitalPatch biosensor, Device: DynaPort Move MonitorParticipants with established diagnosis of heart failure with reduced ejection fraction (HFrEF; EF ≤ 35%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
| HFpEF | Experimental | Device: AVIVO Mobile Patient Management (MPM) System, Device: VitalPatch biosensor, Device: DynaPort Move MonitorParticipants with established diagnosis of heart failure with preserved ejection fraction (HFpEF; EF ≥ 45%) wore the AVIVO MPM System or VitalPatch biosensor for 5 monitoring periods with patches applied on Day 0, 9, 16, 77 and 84; and the DynaPort Move Monitor belt for 2 monitoring periods with belts applied on Day 9 and Day 77. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVIVO Mobile Patient Management (MPM) SystemWearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study | Device | HFpEF, HFrEF |
| VitalPatch biosensorWearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study | Device | HFpEF, HFrEF |
| DynaPort Move MonitorWearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study | Device | HFpEF, HFrEF |
Primary outcome
Daily Steps Count
Time frame: At Day 9 and Day 77
Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Daily Physical Activity Level
Time frame: At Day 9 and Day 77
Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity.
Total Daily Energy Expenditure
Time frame: At Day 9 and Day 77
Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Duration of Daily Physical Activity
Time frame: At Day 9 and Day 77
Duration of daily physical activity was measured with DynaPort Move Monitor device.
Time Duration Per Activity Status
Time frame: At Day 9 and Day 77
Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more.
Amount of Daily Physical Activity Measured With VitalPatch Biosensor
Time frame: Up to Day 84
Amount of daily physical activity was collected and measured with VitalPatch biosensor.
Duration of Daily Physical Activity Measured With VitalPatch Biosensor
Time frame: Up to Day 84
Duration of daily physical activity was collected and measured with VitalPatch biosensor.
Intensity of Daily Physical Activity Measured With VitalPatch Biosensor
Time frame: Up to Day 84
Intensity of daily physical activity was collected and measured with VitalPatch biosensor.
33 secondary outcomes
6-minute Walking Distance (6MWD)
Time frame: At Day 84
Sleep Movements
Time frame: Up to Day 84
Sleep Patterns
Time frame: Up to Day 84
Sit-to-stand Behaviour
Time frame: Up to Day 84
Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score
Time frame: At Day 9 and Day 84
Quality of Life as Measured With the PRO - Activity Scores
Time frame: At Day 9 and Day 77
Quality of Life as Measured With the PRO - Change in Activities and Symptoms
Time frame: At Day 9 and Day 77
Copeptin
Time frame: At Day 9 and Day 84
Galectin-3
Time frame: At Day 9 and Day 84
Growth Differentiation Factor 15 (GDF 15)
Time frame: At Day 9 and Day 84
Human Interleukin-1 Receptor 4 / ST2 (sST2)
Time frame: At Day 9 and Day 84
Human Insulin-like Growth Factor Binding (IGFBP7)
Time frame: At Day 9 and Day 84
N-terminal Propeptide of BNP (NT-proBNP)
Time frame: At Day 9 and Day 84
High Sensitive Troponin T (hsTRT)
Time frame: At Day 9 and Day 84
Blood Pressure
Time frame: At Day 9, Day 77 and Day 84
Heart Rate
Time frame: At Day 9, Day 77 and Day 84
Interventricular Septal Wall Thickness
Time frame: At Day 84
Diameter of the Left Ventricle in Diastole
Time frame: At Day 84
Diameter of the Left Ventricle in Systole
Time frame: At Day 84
Left Ventricular End-diastolic Volume
Time frame: At Day 84
Left Ventricular End-systolic Volume
Time frame: At Day 84
Left Ventricular Ejection Fraction
Time frame: At Day 84
Left Atrial End-systolic Volume
Time frame: At Day 84
Left Atrial End Systolic Volume Index
Time frame: At Day 84
Mitral Peak Velocity of Early Filling (E)
Time frame: At Day 84
Mitral Peak Velocity of Late Filling (A)
Time frame: At Day 84
Mitral Lateral Annulus Early Diastolic Peak Velocity
Time frame: At Day 84
Mitral Septal Annulus Early Diastolic Peak Velocity
Time frame: At Day 84
Tricuspid Annular Plane Systolic Excursion
Time frame: At Day 84
Pressure Gradient of Tricuspid Valve
Time frame: At Day 84
Right Atrial Mean Pressure
Time frame: At Day 84
Heart Rate Variability (HRV) Derived From ECG
Time frame: Up to Day 84
Number of Participants Per NYHA Classification by Visit
Time frame: At Day 9 and Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor and DynaPort Move Monitor in people with Heart Failure, run by Bayer at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Steps Count (time frame: At Day 9 and Day 77). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.